IMPELLA
Report
- Report Number
- 1220648-2026-05524
- Event Type
- Death
- Date Received
- March 18, 2026
- Date of Event
- March 9, 2026
- Report Date
- May 28, 2026
- Manufacturer
- ABIOMED, INC. - 1220648
- Product Code
- OZD
- UDI-DI
- 00813502012279
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A24 REMOVED FROM H6. CORRECTED DATA: D1 UPDATED/CORRECTED. THE INVESTIGATION IS STILL ONGOING.
A5 IS UNKNOWN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
CORRECTED INFORMATION WAS PROVIDED IN D3 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN D4 (CATALOG, SERIAL NUMBER). UPON REVIEW, THE SECTION D CATALOG NUMBER AND SERIAL NUMBER HAVE NOW BEEN UPDATED. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF LOW OR BLOCKED PUMP FLOW WAS MOST LIKELY PATIENT CONDITION RELATED SINCE THE CLINICAL TEAM CONFIRMED THE ISSUE WAS DUE TO THE PATIENT WAS UNDERLYING CRITICAL CARDIAC CONDITION AND EMERGENT COMPLICATIONS RATHER THAN IMPELLA DEVICE PERFORMANCE.
THIS REPORT IS BEING SUBMITTED TO CORRECT H1 CAPTURED UNDER FOLLOW-UP REPORT 01. UPON FURTHER REVIEW, THE REPORT TYPE SELECTED IN THAT SUBMISSION WAS DETERMINED TO BE INCORRECT AND THE REPORT HAS BEEN UPDATED ACCORDINGLY TO ACCURATELY REFLECT THE APPROPRIATE REPORTABLE EVENT CATEGORY. ADDITIONALLY, THE FOLLOWING SECTIONS HAVE BEEN UPDATED: D4 UDI NUMBER UPDATED.
A 47-YEAR-OLD FEMALE WITH AN INDICATION FOR ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, WITH A PRE SUPPORT CLINICAL STATE CONSISTENT WITH SCAI SHOCK STAGE D, UNDERWENT ATTEMPTED HEMODYNAMIC STABILIZATION WITH AN IMPELLA CP DEVICE. UPON PANNING THE C ARM TO THE OPPOSITE SIDE OF THE TABLE, THE CLINICAL TEAM NOTED WHAT APPEARED TO BE A LARGE ASCENDING AORTIC DISSECTION. CONCURRENTLY, THE PATIENT EXPERIENCED A RHYTHM CHANGE ACCOMPANIED BY A DROP IN IMPELLA FLOW. ESCALATION OF VASOPRESSOR SUPPORT WAS REQUIRED, AND MULTIPLE CATHETERS WERE USED TO ATTEMPT VISUALIZATION OF THE LEFT CORONARY SYSTEM, WHICH WAS EVENTUALLY ACHIEVED AND DEMONSTRATED A SIGNIFICANT LEFT MAIN CORONARY OBSTRUCTION. THIS EVENT NARRATIVE REFLECTS A COMPLEX, HIGH ACUITY CLINICAL SCENARIO INVOLVING CARDIOGENIC SHOCK, SEVERE CORONARY ARTERY DISEASE, AND A SUSPECTED ACUTE AORTIC PATHOLOGY IDENTIFIED INTERPROCEDURALLY. THE PATIENT¿S DETERIORATION AND DEATH APPEAR RELATED TO THE UNDERLYING CRITICAL CARDIAC CONDITION AND EMERGENT COMPLICATIONS RATHER THAN IMPELLA DEVICE PERFORMANCE. NO DEVICE MALFUNCTION WAS REPORTED, IMPELLA FLOWS INITIALLY OPERATED WITHIN EXPECTED RANGES, AND THE CLINICAL TEAM DID NOT ALLEGE IMPELLA INVOLVEMENT. THE SEQUENCE OF EVENTS SUGGESTS THAT THE PROGRESSION OF CARDIOGENIC SHOCK, THE NEWLY IDENTIFIED LEFT MAIN CORONARY OBSTRUCTION, AND THE SUSPECTED AORTIC DISSECTION CONTRIBUTED TO THE PATIENT¿S DECLINE AND ULTIMATE INABILITY TO ACHIEVE A SURVIVABLE RHYTHM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 370537 | IMPELLA | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. - 1220648 | 2027842777 | 00813502012279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |