IMPELLA
Report
- Report Number
- 1220648-2026-04460
- Event Type
- Death
- Date Received
- March 4, 2026
- Date of Event
- February 23, 2026
- Manufacturer
- ABIOMED, INC. - 1220648
- Product Code
- OZD
- UDI-DI
- 00813502012828
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT REPORTING THE DEVICE IS NOT AVAILABLE FOR RETURN.
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 D1 (BRAND NAME). UPON REVIEW, IT WAS IDENTIFIED THAT THE SECTION D BRAND NAME HAS NOW BEEN UPDATED. CORRECTED INFORMATION WAS PROVIDED IN D3, G1 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN D4 (CATALOG). UPON REVIEW, THE SECTION D CATALOG NUMBER HAS NOW BEEN UPDATED. CORRECTED INFORMATION WAS PROVIDED IN E1 (ZIP CODE EXTENSION). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN E3 (INITIAL REPORTER OCCUPATION). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY SUBMITTED IN ERROR IN THE INITIAL REPORT. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE POSITIONING ISSUE WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.
CLINICAL RATIONALE: AN IMPELLA 5.5 DEVICE WAS INSERTED INTO THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN A 67-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD) AND DIABETES, PRESENTING IN SCAI STAGE C SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT DURING A HIGH-RISK PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, THE PATIENT HAD AN EPISODE OF VENTRICULAR TACHYCARDIA (VT) REQUIRING CARDIOVERSION. THE IMPELLA WAS PULLED BACK 3 CM UNDER ECHOCARDIOGRAM. ONE WEEK AFTER IMPELLA INSERTION, THE FAMILY ELECTED TO WITHDRAW CARE, AND THE PATIENT EXPIRED ON SUPPORT. THE IMPELLA FUNCTIONED AT P.4 AT 3.6L/MIN AS INTENDED. ARRYTHMIAS MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS CRITICAL ILLNESS, UNDERLYING CARDIAC DYSFUNCTION, HEMODYNAMIC INSTABILITY, AND IMPROPER DEVICE POSITION. IMPELLA SUPPORT IS KNOWN TO CAUSE CARDIAC ARRHYTHMIAS, LIKELY DUE TO THE MECHANICAL IRRITATION OF THE HEART. THE IMPELLA IS CONSERVATIVELY BEING REPORTED FOR DEATH; HOWEVER, IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT'S DEATH, WHICH WAS MOST LIKELY DUE TO THE CLINICAL CONDITION OF A CRITICALLY ILL PATIENT COMPLICATED WITH STAGE C SHOCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 186956 | IMPELLA | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. - 1220648 | 2026812363 | 00813502012828 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |