IMPELLA CP
Report
- Report Number
- 1220648-2025-48221
- Event Type
- Death
- Date Received
- November 10, 2025
- Date of Event
- October 12, 2025
- Report Date
- November 10, 2025
- Manufacturer
- ABIOMED, INC.
- Product Code
- OZD
- UDI-DI
- 00813502012279
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED. AS NOTED IN THE IMPELLA INSTRUCTIONS FOR USE: IMPELLA CP WITH SMARTASSIST FOR USE DURING CARDIOGENIC SHOCK AND HIGH RISK PERCUTANEOUS CORONARY INTERVENTION SECTION: WARNINGS, CAUTIONS, AND PRECAUTIONS ¿TO REDUCE THE POSSIBILITY OF FIBERS BEING DRAWN INTO THE IMPELLA, CUSTOMERS SHOULD AVOID EXPOSING THE INLET AND CANNULA SECTION OF THE IMPELLA HEART PUMPS TO ANY SURFACES OR FLUID BATHS WHERE THE DEVICE CAN COME INTO CONTACT WITH LOOSE OR FLOATING FIBERS.¿
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: LOW OR BLOCKED PUMP FLOW/PUMP SUCTION: THE CAUSE OF THE ISSUE WAS UNABLE TO BE DETERMINED AS NO PRODUCT WAS RETURNED FOR ANALYSIS AND NO CONCLUSIONS COULD BE DRAWN FROM CLINICAL INFORMATION AND LOG ANALYSIS. HEMODYNAMIC INSTABILITY: THE CAUSE OF THE ISSUE WAS NOT ESTABLISHED AS LIMITED CLINICAL INFORMATION WAS PROVIDED DEVICE HISTORY LOT: DEVICE LOT NUMBER: 1961530. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: THE PUMP SN (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS. QN #(B)(4) NOTED PUMP SN (B)(6) FROM LOT 1961530 HAD A TRAY SEAL ISSUE AND HAD REWORKS.
MEDICAL SAFETY/CLINICAL REVIEWED THE EVENT. A 71-YEAR-OLD FEMALE WITH UNKNOWN PRIOR MEDICAL HISTORY PRESENTED FOR A SCHEDULED THREE-VESSEL CORONARY ARTERY BYPASS GRAFT (3V CABG) PROCEDURE. UPON COMPLETION OF THE CABG AND DURING TRANSFER FROM THE OPERATING ROOM TABLE TO THE BED, THE PATIENT EXPERIENCED CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. THE CHEST WAS REOPENED, AND THE RIGHT CORONARY ARTERY (RCA) GRAFT WAS FOUND TO BE OCCLUDED. THE GRAFT WAS REVISED. DUE TO ONGOING HEMODYNAMIC INSTABILITY, A DECISION WAS MADE TO PROCEED WITH IMPELLA 5.5 INSERTION VIA THE AXILLARY APPROACH. HOWEVER, THERE WAS DIFFICULTY ADVANCING THE DEVICE ACROSS THE AORTIC VALVE INTO THE LEFT VENTRICLE. DESPITE MULTIPLE ATTEMPTS, THE IMPELLA 5.5 COULD NOT BE ADVANCED FROM THE AXILLARY ARTERY INTO THE AORTA. THE PROCEDURE WAS ABORTED. THE PHYSICIAN THEN PROCEEDED WITH PLACEMENT OF AN IMPELLA CP VIA RIGHT FEMORAL ARTERY (RFA) ACCESS, WHICH WAS SUCCESSFULLY IMPLANTED. SUPPORT WAS INITIATED AT P-2; HOWEVER, THE DEVICE WAS UNABLE TO PROVIDE FLOWS ABOVE P-1 WITHOUT SUCTION ALARMS. FLUOROSCOPY AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) CONFIRMED APPROPRIATE DEVICE POSITIONING. THE PATIENT REQUIRED MULTIPLE BLOOD PRODUCT TRANSFUSIONS THROUGHOUT THE DAY. VOLUME ADMINISTRATION DID NOT RESOLVE THE SUCTION EVENTS, AND PUMP FLOW REMAINED LIMITED TO APPROXIMATELY 0.5 L/MIN OR LESS. GIVEN PERSISTENT HEMODYNAMIC INSTABILITY AND INABILITY TO ACHIEVE ADEQUATE FLOW DESPITE CONFIRMED POSITIONING AND VOLUME RESUSCITATION, THE PHYSICIAN DECIDED TO DISCONTINUE MECHANICAL SUPPORT. THE PATIENT SUBSEQUENTLY EXPIRED. THE UNSUCCESSFUL ATTEMPT TO IMPLANT THE IMPELLA 5.5 DUE TO INABILITY TO ADVANCE WILL BE REPORTED AS A MALFUNCTION-TYPE REPORTABLE EVENT. THE DEATH WILL BE REPORTED AGAINST THE IMPELLA CP. HOWEVER, THE PATIENT¿S DEATH IS MOST LIKELY ATTRIBUTABLE TO THE POSTOPERATIVE CARDIOGENIC SHOCK FOLLOWING CABG COMPLICATED BY INTRAOPERATIVE GRAFT FAILURE AND CARDIAC ARREST, WITH ONGOING HEMODYNAMIC INSTABILITY DESPITE SURGICAL REVISION, TRANSFUSION SUPPORT, AND MECHANICAL CIRCULATORY SUPPORT. CODING. PATIENT CODING WAS UPDATED FOLLOWING MEDICAL SAFETY AND CLINICAL REVIEW AS FOLLOWS: REMOVED: DEVICE EXPLANTATION (F1903) AND NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS (E2403) AS THE PATIENT WAS HEMODYNAMICALLY UNSTABLE AND REQUIRED BLOOD TRANSFUSION. ADDED: HEMODYNAMIC INSTABILITY (E2343) AND BLOOD TRANSFUSION (F2302). THEREFORE, SECTION H6 (HEALTH EFFECT ¿ CLINICAL CODE, HEALTH EFFECT ¿ IMPACT CODE, AND MEDICAL DEVICE PROBLEM CODE) HAS BEEN FULLY REPOPULATED AND SHOULD BE REGARDED AS THE FINAL CODING THAT ACCURATELY REFLECTS THE REPORTED EVENT. RELATED MEDICAL DEVICE REPORTS: THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER(S) AS NOTED IN SECTION H10.
THE INVESTIGATION OF THE REPORTED FAILURE MODE HAS BEEN COMPLETED. NO PRODUCT WAS RECEIVED FOR EVALUATION. LOW OR BLOCKED PUMP FLOW/PUMP SUCTION: THE LOGS CONFIRM SUCTION ALARMS A REVIEW OF THE LOGS CONFIRM SUCTION TRIGGERS ARE CORRECT SUGGESTING PATIENT IS EXPERIENCING SUCTION AT BOTH PHASES OF THE CARDIAC CYCLE WITH LOW MOTOR CURRENT (MC) MAX VALUES AND LOW FLOWS DURING SYSTOLE. LOGS ALSO SHOWED PUMP FLOWS WERE AVERAGING 0.35 L/MIN (SPEC: 0.0 - 0.9L/MIN) WHEN AT P1 AND AVERAGING 0.7L/MIN. THE CAUSE OF THE ISSUE WAS UNABLE TO BE DETERMINED AS NO PRODUCT WAS RETURNED FOR ANALYSIS AND NO CONCLUSIONS COULD BE DRAWN FROM CLINICAL INFORMATION AND LOG ANALYSIS. DEVICE HISTORY REVIEW: THE DEVICE PASSED ALL THE POST STERILE INSPECTION CHECKS.
THE COMPLAINANT REPORTED THAT THERE WAS PUMP SUCTION AND LOW PUMP FLOW DURING IMPELLA CP PATIENT SUPPORT. WHILE ON SUPPORT, THE DEVICE WAS UNABLE TO FLOW ABOVE PERFORMANCE LEVEL 1 WITHOUT SUCTION. FLUOROSCOPY AND TRANSESOPHAGEAL ECHOCARDIOGRAM CONFIRMED OPTIMAL PLACEMENT. VOLUME DID NOT RESOLVE THE SUCTION EVENT AND THE DEVICE WAS UNABLE TO FLOW ABOVE 0.5 LITERS PER MINUTE. THE DOCTOR DECIDED TO ABORT AND THE PATIENT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 274564 | IMPELLA CP | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. | IMPELLA CP | 2026730516 | 00813502012279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |