Procedure-Related Mortality in Aspiration Thrombectomy for Pulmonary Embolism: A MAUDE Database Analysis of the Inari FlowTriever and Penumbra Indigo Systems
Bibliographic record
Abstract
BACKGROUND: Pulmonary embolism (PE) is an important cause of death and disability. Advances in catheter-directed therapies have led to the use of devices, such as the Inari FlowTriever and Penumbra Indigo system for aspiration thrombectomy (AT) for both massive and sub-massive PE. However, limited data exist on causes of procedural mortality. METHODS: Analysis of the Food and Drug Administration's (FDA) Manufacture and User Facility Device Experience (MAUDE) database was performed. Data for the Inari FlowTriever and Penumbra Indigo aspiration thrombectomy systems were evaluated for mortality events and classified by cause of death from January 1, 2015, to December 31, 2023. RESULTS: The review identified 26 mortality events related to the Inari FlowTriever and 28 related to the Penumbra Indigo device. Pulmonary vascular perforation (n=26) and right heart injury/tamponade (n=9) were the most common source of mortality. Clot migration (n=4) and acute right heart failure (n=5) were less frequently observed. CONCLUSIONS: This study reveals more mortality events than have been captured in the literature to date. Vascular perforation and cardiac injury are the most common and also potentially preventable sources of mortality. Strategies to mitigate complications related to aspiration thrombectomy are described.Clinical ImpactAnalysis of mortality in aspiration thrombectomy (AT) for acute pulmonary embolism is necessary to better understand the safety profile of this procedure. This analysis of the MAUDE database reports the largest single cohort of 54 deaths. Potentially preventable procedure-related mortality in AT has been documented to be the result of vascular perforation and cardiac perforation with tamponade. Preparation for emergent pericardiocentesis should be considered in mechanical thrombectomy. Clot migration may result from thrombus maceration or migration of clot in transit, thus, careful pre-procedure examination for clot in transit with echocardiography is suggested.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.015 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.004 |
| Bibliometrics | 0.008 | 0.008 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".