PUMP 381 PUMP SET (US)
Report
- Report Number
- 1220648-2026-02930
- Event Type
- Death
- Date Received
- February 11, 2026
- Date of Event
- December 1, 2025
- 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
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B2 DEATH AND DATE OF DEATH ADDED. B5 UPDATED WITH PATIENT OUTCOME. H1 AND H6 REVISED TO REFLECT THE PATIENT OUTCOME. THE EXACT DATE OF DEATH IS UNKNOWN BUT HAS BEEN CAPTURED AS THE DATE OF EXPLANT. IF ADDITIONAL INFORMATION BECOMES KNOWN, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
ADDED B1 (PRODUCT PROBLEM) ADDITIONAL INFORMATION HAS BEEN PROVIDED IN B5 (EVENT DESCRIPTION) AND D9 SINCE DEVICE WAS RETURNED. CORRECTED D4 (PRIMARY UDI NUMBER) 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 IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.
CLINICAL RATIONALE (UPDATED): AN (B)(6)-YEAR-OLD MALE PATIENT WITH AORTIC STENOSIS UNDERWENT BALLOON AORTIC VALVULOPLASTY (BAV) PRIOR TO IMPELLA CP IMPLANTATION. HIS COMORBIDITIES INCLUDED KNOWN CORONARY ARTERY DISEASE AND RENAL INSUFFICIENCY. UPON IMPELLA INSERTION, THE PUMP EXHIBITED SUCTION AND LOW FLOWS. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED, AND A LARGE PERICARDIAL EFFUSION WAS IDENTIFIED. LEFT-VENTRICULAR PERFORATION WAS SUSPECTED. THE CARE TEAM ELECTED TO REMOVE THE IMPELLA AND PROCEED TO EMERGENT SURGERY. THE PHYSICIAN STATED IT WAS UNKNOWN WHETHER THE PERFORATION RESULTED FROM THE BAV WIRE OR FROM THE IMPELLA DEVICE. NO ADDITIONAL STATEMENTS WERE MADE REGARDING SUSPECTED CAUSALITY. THE PATIENT EXPIRED. THE DEVICE WILL BE CONSERVATIVELY REPORTED FOR DEATH; HOWEVER, THE DEATH IS MOST LIKELY ATTRIBUTABLE TO THE PATIENT¿S UNDERLYING STRUCTURAL HEART DISEASE, CARDIOGENIC SHOCK PHYSIOLOGY, AND THE CATASTROPHIC COMPLICATION OF SUSPECTED VENTRICULAR PERFORATION.
ADDITIONAL INFORMATION INDICATES THAT THE PATIENT EXPIRED. FROM THE PHYSICIAN¿S STANDPOINT, NO COMMENT WAS MADE REGARDING WHETHER THE BAV WIRE OR THE IMPELLA DEVICE MAY HAVE CAUSED THE PERFORATION. THE PUMP WAS SENT BACK.
A 89 YEAR-OLD MALE PATIENT WITH AORTIC STENOSIS, BALLOON AORTIC VALVULOPLASTY (BAV)PROCEDURE PERFORMED PRIOR TO IMPELLA CP IMPLANT. PUMP HAD SUCTION AND LOW FLOWS ON INSERTION. CPR STARTED AND THERE WAS A LARGE PERICARDIAL EFFUSION FOUND. SUSPECTED LV PERFORATION. DECISION MADE BY TEAM TO REMOVE IMPELLA TAKE TO EMERGENT SURGERY. OUTCOME UNKNOWN. PHYSICIAN STATED IT IS UNKNOWN WHETHER PERFORATION OCCURRED FROM THE BAV OR IMPELLA, THUS IMPELLA TO BE CONSERVATIVELY CODED TO CARDIAC PERFORATION, CARDIAC TAMPONADE, AND SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 377115 | PUMP 381 PUMP SET (US) | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. - 1220648 | PUMP 381 PUMP SET (US) | 2026770277 | 00813502012279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Male | Death| R |