IMPELLA
Report
- Report Number
- 1220648-2026-06961
- Event Type
- Death
- Date Received
- April 20, 2026
- Date of Event
- April 14, 2026
- Manufacturer
- ABIOMED, INC. - 1220648
- Product Code
- OZD
- UDI-DI
- 00813502012828
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE PUMP IS CURRENTLY STILL IN THE PATIENT. 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 HAS BEEN PROVIDED IN D4 (CATALOG AND SERIAL). PPAE (THROMBOCYTOPENIA): THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.
THIS REPORT IS BEING SUBMITTED TO CORRECT (B2, B5, H1, H6) CAPTURED UNDER THE INITIAL REPORT. 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. 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 (PRIMARY UDI NUMBER). UPON REVIEW, THE SECTION D PRIMARY UDI NUMBER HAS NOW BEEN UPDATED. 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. ADDITIONAL INFORMATION WAS PROVIDED IN D6B (EXPLANT DATE), D10 (CONCOMITANT PRODUCT). UPON REVIEW, IT WAS IDENTIFIED THAT EXPLANT DATE AND CONCOMITANT PRODUCT HAVE NOW BEEN UPDATED.
CLINICAL NARRATIVE: AN IMPELLA 5.5 DEVICE WAS INSERTED VIA A RIGHT AXILLARY/SUBCLAVIAN SURGICAL ARTERIAL APPROACH IN A 64-YEAR-OLD MALE PATIENT FOR ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), PRESENTING IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE D CARDIOGENIC SHOCK. DURING IMPELLA 5.5 SUPPORT, THE PATIENT WAS IDENTIFIED AS HEPARIN-INDUCED THROMBOCYTOPENIA (HIT) POSITIVE, AND SYSTEMIC ANTICOAGULATION WAS TRANSITIONED FROM HEPARIN TO BIVALIRUDIN. THE PATIENT REMAINED ON IMPELLA 5.5 SUPPORT AT THE TIME OF REPORTED EVENT. ANTICOAGULATION MANAGEMENT IN PATIENTS RECEIVING MECHANICAL CIRCULATORY SUPPORT MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS HIT, CRITICAL ILLNESS, AND CARDIOGENIC SHOCK; ALTERNATIVE ANTICOAGULANTS SUCH AS BIVALIRUDIN ARE ROUTINELY USED IN THIS SETTING TO MITIGATE THROMBOTIC RISK WHILE BALANCING BLEEDING RISK.
THE IMPELLA 5.5 SUPPORTED THE PATIENT FOR 7 DAYS WHEN THE DECISION WAS MADE TO WITHDRAW CARE. THE PUMP HAD SUPPORTED IN COMBINATION WITH THE EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO). THE 5.5 PUMP PROVIDED VENTING TO THE PRIMARY SUPPORT DEVICE ECMO. MORTALITY IS AN EXPECTED RISK WITH MULTIPLE MECHANICAL SUPPORT DEVICES AND NATIVE CRITICAL CONDITION. THE PATIENT HAD PRESENTED IN CARDIOGENIC SHOCK AND SCAI STAGE D SHOCK. THE DEATH IS BEING CONSERVATIVELY REPORTED; HOWEVER, BASED ON THE AVAILABLE INFORMATION, THE PATIENT¿S DEATH IS MORE LIKELY ATTRIBUTABLE TO THE REPORTED ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK. AN IMPELLA 5.5 DEVICE WAS INSERTED VIA A RIGHT AXILLARY/SUBCLAVIAN SURGICAL ARTERIAL APPROACH IN A 64-YEAR-OLD MALE PATIENT FOR ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), PRESENTING IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE D CARDIOGENIC SHOCK. DURING IMPELLA 5.5 SUPPORT, THE PATIENT WAS IDENTIFIED AS HEPARIN-INDUCED THROMBOCYTOPENIA (HIT) POSITIVE, AND SYSTEMIC ANTICOAGULATION WAS TRANSITIONED FROM HEPARIN TO BIVALIRUDIN. THE PATIENT REMAINED ON IMPELLA 5.5 SUPPORT AT THE TIME OF REPORTED EVENT. ANTICOAGULATION MANAGEMENT IN PATIENTS RECEIVING MECHANICAL CIRCULATORY SUPPORT MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS HIT, CRITICAL ILLNESS, AND CARDIOGENIC SHOCK; ALTERNATIVE ANTICOAGULANTS SUCH AS BIVALIRUDIN ARE ROUTINELY USED IN THIS SETTING TO MITIGATE THROMBOTIC RISK WHILE BALANCING BLEEDING RISK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 510845 | IMPELLA | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. - 1220648 | 2027846559 | 00813502012828 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |