BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 22988076 · Received September 6, 2025

    Report

    Report Number
    1220648-2025-46195
    Event Type
    Death
    Date Received
    September 6, 2025
    Date of Event
    August 7, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: PUMP (B)(6) AND PURGE TUBE RETURNED + DATA STICK RETURNED SEPARATELY ON 9/2/2025. PUMP STOP - AFTER 12 DAYS ON SUPPORT, PUMP STOP OCCURRED. DATA LOG REVIEW CONFIRMED PUMP RAN FOR 12 DAYS, WITH PUMP STOP OCCURRING WITH MC SPIKE. THE RETURNED PRODUCT RECREATED THE PUMP STOP UPON ATTEMPTED RESTART AND IMAGING UNDER THE KEYENCE SHOWN A LARGE IMPELLA PURGE GAP, INDICATIVE OF BEARING WEAR. THE CAUSE OF THE PUMP STOP WAS MATERIAL WEAR RELATED TO THE BALL BEARINGS. THIS CP PUMP FAILED ON DAY 12 OF SUPPORT, BEYOND THE INTENDED DESIGN LIFE OF A PP OF 8 DAYS PER DESIGN TRACE MATRIX (B)(4). DEVICE HISTORY LOT: DEVICE LOT: 1833664. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW : Q1) ANY QNS/MRRS/REWORKS ASSOCIATED WITH THE COMPLAINT DEVICE: NO. Q2) WERE THERE ANY FAILURES OF THE DEVICE TO MEET THE REQUIREMENTS FOR MANUFACTURING TESTING, QUALIFICATION, AND INSPECTION?: NO. Q3) WERE THERE ANY OTHER PRODUCT MALFUNCTION COMPLAINTS IN THIS DEVICE LOT RELATED TO THIS FAILURE MODE?: NO. PHR SUMMARY: S/N (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER. THEREFORE, INVESTIGATION OF THE DEVICE IS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. THE IFU STATES: IMPELLA CP WITH SMARTASSIST FOR USE DURING CARDIOGENIC SHOCK SECTION: TROUBLESHOOTING THE PURGE SYSTEM ¿UNRESOLVED PURGE PRESSURE HIGH ALARM IF NOT RESOLVED BY THE RECOMMENDATIONS PROVIDED, HIGH PURGE PRESSURE¿WHICH TRIGGERS THE ¿PURGE PRESSURE HIGH¿ ALARM MESSAGE¿COULD BE AN INDICATION OF A KINK IN THE IMPELLA CATHETER. IN THIS CASE, THE MOTOR IS NO LONGER BEING PURGED AND MAY EVENTUALLY STOP.¿ SECTION: IMPELLA STOPPED ¿IF THE IMPELLA CATHETER HAS STOPPED SUDDENLY: 1. TRY TO RESTART THE CATHETER AT PREVIOUS P-LEVEL. 2. IF THE IMPELLA DOES NOT RESTART, TRY TO RESTART AT P-2. 3. IF THE IMPELLA DOES NOT RESTART OR STOPS AGAIN, WAIT 1 MINUTE AND TRY TO RESTART AGAIN. 4. IF THE IMPELLA RESTARTS, WEAN DOWN TO P-2 AS THE PATIENT CAN TOLERATE. UNDER THESE CIRCUMSTANCES, CATHETER FUNCTION IS NOT RELIABLE AND THE IMPELLA MAY STOP AGAIN. 5. IF THE IMPELLA DOES NOT RESTART, REMOVE THE IMPELLA FROM THE VENTRICLE AS SOON AS POSSIBLE TO AVOID AORTIC INSUFFICIENCY.¿.

    Additional Manufacturer Narrative · 0

    MEDICAL SAFETY REVIEW WAS COMPLETED AND NOTED THE FOLLOWING: THE EVENT DESCRIBES A PUMP STOP/FAILURE WITH IMPELLA CP PUMP 1 AND SUCTION EVENTS REQUIRING INTERVENTION WITH IMPELLA CP PUMP 2, WHICH CONTRIBUTED TO THE SERIOUS INJURY. HOWEVER, THERE IS NOT ENOUGH INFORMATION TO EXCLUDE IMPELLA CP PUMP 1 AS AN ASSOCIATED FACTOR IN THE DEMISE OUTCOME. THE IMMEDIATE ISSUE IS THE PUMP FAILURE AND IS WHAT LED TO OR CONTRIBUTED MORE TO THE DEMISE OUTCOME. MEDICAL SAFETY OFFICER REVIEWED THE EVENT AND NOTED THE SAME IN THAT THE IMPELLA CP PUMP 1 CANNOT BE DISSOCIATED FOR THE DEMISE OUTCOME AND IMPELLA CP PUMP 2 EVENT RESULTED IN A SERIOUS INJURY AND SHOULD BE REPORTED. CHANGE IN REPORTABILITY: AFTER REVIEW OF THE CASE BY THE MEDICAL SAFETY OFFICER, IT WAS DETERMINED THE IMPELLA CP PUMP 1 IS A DEATH TYPE OF REPORTABLE EVENT. SECTIONS B1 (ADVERSE EVENT/PRODUCT PROBLEM), B2 (OUTCOMES ATTRIBUTED), H1 (TYPE OF REPORTABLE EVENT) AND H6 (HEALTH EFFECT - CLINICAL AND IMPACT CODES) HAVE BEEN UPDATED, CORRECTED ACCORDINGLY. ADDITIONALLY, SECTION B5 (EVENT DESCRIPTION) WAS UPDATED TO INCLUDE COMPLETE EVENT DETAILS. RELATED MEDICAL DEVICE REPORTS: THIS IMPELLA CP PUMP 1 REPORT IS ONE OF TWO DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER AS NOTED IN SECTION H10 FOR THE MEDICAL DEVICE REPORT ON THE IMPELLA CP PUMP 2. DEVICE STATUS: ADDITIONAL INFORMATION NOTED THE IMPELLA DEVICE PUMP 1 WAS RETURNED, AND AN EVALUATION/ANALYSIS IS UNDERWAY. UPON COMPLETION OF THE ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED. CORRESPONDINGLY, SECTIONS D9: DEVICE RECEIVED BY MANUFACTURER WITH RECEIPT DATE AND H6: INVESTIGATION TYPE, FINDINGS AND CONCLUSION CODES WERE UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WITH CARDIOMYOPATHY WAS IMPLANTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. AFTER 12 DAYS OF IMPELLA CP SUPPORT, THE PUMP HAD SUDDEN PUMP FAILURE WITHOUT RISE IN MOTOR CURRENT UNTIL THE EVENT. THE PUMP AS A RESULT WAS IMMEDIATELY REMOVED AND A NEW IMPELLA CP WAS USED INSTEAD. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WITH CARDIOMYOPATHY WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE FIRST IMPELLA CP PUMP STOPPED AND WAS IMMEDIATELY REPLACED WITH AN IMPELLA CP PUMP 2; HOWEVER, THIS PUMP HAD SUCTION AND REQUIRED INTERVENTION. THE PATIENT WOULD ULTIMATELY EXPIRE. THE PATIENT PRESENTED IN PULSELESS ELECTRICAL ACTIVITY DURING CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATION, RECEIVED CARDIOPULMONARY RESUSCITATION (CPR) AND VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA ECMO) WITH RETURN OF SPONTANEOUS CIRCULATION ACHIEVED POST CANNULATION (THIS OCCURRING THREE DAYS PRIOR TO THE IMPELLA IMPLANT). THERE WAS A NOTED PULMONARY HEMORRHAGE FROM THE CPR; NEURO REMAINED INTACT. HOWEVER, A COMPUTED TOMOGRAPHY SCAN OF THE HEAD SHOWED A 5MM SUBDURAL HEMATOMA. WHILE RECOVERING IN THE INTENSIVE CARE UNIT, IT WAS NOTED THE PATIENT HAD RECURRENT SUPRAVENTRICULAR TACHYCARDIA/VENTRICULAR TACHYCARDIA WHILE ON ECMO. THE DECISION WAS MADE PLACE THE PATIENT ON IMPELLA MECHANICAL CIRCULATORY SUPPORT (MCS) AND PROTEK DUO WITH DECANNULATION OF ECMO. OF NOTE, AN IMPELLA 5.5 WAS CONSIDERED WITH PROTEK DUO. HOWEVER, DUE TO THE NATURE OF THE PATIENT'S SIZE AND VESSELS, THE DECISION WAS MADE TO PLACE IMPELLA CP AXILLARY WHICH WAS SUCCESSFULLY COMPLETED. APPROXIMATELY 13 DAYS AFTER START OF THE IMPELLA MCS, THE PUMP SUDDENLY FAILED/STOPPED. THE PATIENT WAS EMERGENTLY TAKEN CARDIOVASCULAR LAB TO REPLACE THE IMPELLA CP PUMP 1, WHICH WAS REMOVED FROM AXILLARY SITE WITHOUT AN ISSUE. THE SITE WAS THEN CLOSED. A NEW IMPELLA CP PUMP 2 WAS PLACED. HOWEVER, THE NEXT DAY SUCTION ALARM WAS TRIGGERED, AND CONSEQUENTLY, THE PATIENT WAS GIVEN BLOOD AND ALBUMIN. SUBSEQUENTLY, THE NEXT DAY, THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305243 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2025555629 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention| L| D