IMPELLA
Report
- Report Number
- 1220648-2026-05022
- Event Type
- Death
- Date Received
- March 11, 2026
- Date of Event
- March 2, 2026
- Manufacturer
- ABIOMED, INC. - 1220648
- Product Code
- OZD
- UDI-DI
- 00813502012279
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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.
THE DEVICE WAS NOT RETURNED; THEREFORE, EVALUATION AND ANALYSIS COULD NOT BE PERFORMED. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND CONFIRMED THE PUMP PASSED ALL POST STERILE INSPECTION CHECKS. HEMOLYSIS/MECHANICAL INTERACTION WITH BLOOD: THE CAUSE OF HEMOLYSIS WAS NOT DETERMINED DUE TO LACK OF CLINICAL DETAILS, NO PRODUCT OR DATA LOGS RETURNED FOR ANALYSIS. DEVICE IN WRONG POSITION: THE CAUSE OF POSITION ISSUE WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS AND NO PRODUCT WAS RETURNED. H6 COMPONENT CODING AND INVESTIGATION TYPE, FINDINGS AND CONCLUSION CODING HAVE BEEN UPDATED BASED ON THE COMPLETED INVESTIGATION. CORRECTION. D4 UNIQUE DEVICE IDENTIFIER WAS UPDATED, CORRECTED ACCORDINGLY.
THIS FOLLOW UP MDR IS BEING SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION RECEIVED FROM THE SALES REPRESENTATIVE CONFIRMING THAT THERE IS NO DEVICE AVAILABLE FOR RETURN. THIS INFORMATION IS CONSISTENT WITH THE INITIAL MDR, WHICH REPORTED THAT THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. AS NO DEVICE IS AVAILABLE, DEVICE EVALUATION COULD NOT BE PERFORMED. NO ADDITIONAL INFORMATION IMPACTING THE PREVIOUSLY REPORTED DEVICE RETURN STATUS IS AVAILABLE AT THIS TIME.
CORRECTED INFORMATION HAS BEEN PROVIDED IN D1 BRAND NAME. CORRECTED INFORMATION HAS BEEN PROVIDED IN D4 SERIAL NUMBER. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF HEMOLYSIS WAS NOT DETERMINED DUE TO LACK OF CLINICAL DETAILS, NO PRODUCT OR DATA LOGS RETURNED FOR ANALYSIS. THE CAUSE OF POSITION ISSUE WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS AND NO PRODUCT WAS RETURNED.
CLINICAL REVIEW/RATIONALE: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 62-YEAR-OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE E SHOCK. PRIOR TO THE PUMP PLACEMENT THE PATIENT WAS KNOWN TO HAVE AN OUT OF HOSPITAL CARDIAC ARREST AND BE ON INOTROPES, VASOPRESSORS, AND A VENT FOR RESPIRATORY NEEDS. UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE PUMP WAS SUPPORTING FOR JUST A DAY WHEN THERE WAS HEMOLYSIS CONCERNS DUE TO PRESUMED MAL-POSITIONING. THE FAMILY AND MEDICAL TEAM WITHDREW CARE. HEMOLYSIS MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS CRITICAL ILLNESS, UNDERLYING CARDIAC DYSFUNCTION, HEMODYNAMIC INSTABILITY, RENAL FUNCTION, ANTICOAGULATION STATUS, AND POTENTIAL DEVICE POSITION. THE DEATH IS CONSERVATIVELY BEING REPORTED ALTHOUGH AN UNLIKELY CONTRIBUTING FACTOR TO THE DEATH, AND MORE LIKELY THE PATIENT'S PRESENTING NATIVE CRITICAL CONDITION AS PRESENTED IN SCAI STAGE E.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 603719 | IMPELLA | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. - 1220648 | 2026737685 | 00813502012279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |