BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 6962433 · Received October 19, 2017

    Report

    Report Number
    1220648-2017-00076
    Event Type
    Injury
    Date Received
    October 19, 2017
    Date of Event
    September 17, 2017
    Report Date
    September 19, 2017
    Manufacturer
    ABIOMED EUROPE GMBH
    Product Code
    OZD
    UDI-DI
    00813502011258
    PMA / PMN Number
    P1400003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPELLA CP WAS NOT RETURNED FOR EVALUATION, AND THE CONSOLE DATA LOGS ARE IRRELEVANT TO THIS CASE. A REVIEW OF THE CLINICAL CASE WAS DONE. THE REPOSITIONING UNIT (P/N 002164) WAS PART OF LOT BATCH 1264867, AND WAS MANUFACTURED AT ABIOMED, INC. IN (B)(4). THERE ARE NO COMPLAINTS FOR OTHER REPOSITIONING UNITS IN THIS LOT. THE VALVE SUBASSEMBLY OF THE REPOSITIONING UNIT (P/N 0046-0552) WAS PART OF LOT BATCH 0122015 AND WAS INSPECTED IN THE REPOSITIONING UNIT (P/N 002164) AND WAS PART OF BATCH 1264867, WHICH WAS ALSO MADE IN ABIOMED, INC. IN (B)(4). THERE ARE NO COMPLAINTS FOR OTHER REPOSITIONING UNITS IN THIS LOT. THE VALVE SUBASSEMBLY OF THE REPOSITIONING UNIT (P/N 0046-0552) WAS PART OF BATCH 0122015 AND WAS INSPECTED AT ABIOMED, INC. IN (B)(4) ON 10/28/2016. THE LOT PASSED INSPECTION AND THERE ARE NO COMPLAINTS FOR OTHER VALVE SUBASSEMBLIES IN THIS LOT. THIS FAILURE MODE WAS DETERMINED TO BE LOW RISK DUE TO VERY LOW OCCURRENCE ((B)(4)) AND MODERATE SEVERITY. THE ROOT CAUSE OF THE BLOOD LEAKING FROM THE REPOSITIONING UNIT INTO THE STERILE SLEEVE WAS UNABLE TO BE DETERMINED BECAUSE THE PRODUCT WAS NOT RETURNED. NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME BECAUSE THE FAILURE MODE WAS DETERMINED TO HAVE A LOW RISK INDEX BASED ON VERY LOW OCCURRENCE AND MODERATE SEVERITY. FAILURES OF THIS TYPE WILL CONTINUE TO BE MONITORED AND TRENDED. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO CORRECT THE SECOND PARAGRAPH OF THE EVENT DESCRIPTION CONTAINED IN INITIAL MEDWATCH REPORT 1220648-2017-00076. THE SECOND PARAGRAPH SHOULD HAVE STATEDTHE FOLLOWING: AFTER TRANSFER OF THE PATIENT TO THE ICU, PATIENT BLEEDING WAS OBSERVED: BLOOD WAS LEAKING INTO THE STERIL REPOSITIONING SLEEVE ON THE CATHETER. THE BLEEDING WAS THOUGHT TO BE COMING FROM THE BACK OF THE REPOSITIONING SHEATH, BUT CLOSER OBSERVATION BY THE CLINICIANS REVEALED THAT DAMAGE HAD OCCURRED TO THE HEMOSTATIC VALVE/ RING INSIDE THE REPOSITIONING SHEATH. THE CLINICIANS REPORTED THAT IT WAS ASSUMED THAT THE DAMAGE TO THE VALVE WAS DUE TO THE REPEATED IN AND OUT MOVEMENTS AND MANIPULATIONS OF THE IMPELLA CATHETER DURING INSERTION. THE CLINICIANS CONSIDERED REPLACING THE PUMP; HOWEVER, CONSIDERING THE VERY DIFFICULT INITIAL PLACEMENT PROCEDURE, THEY DECIDED TO CONTINUE WITH THE PUMP WITH THE BLEEDING REPOSITIONING SHEATH. THE PATIENT WAS SUPPORTED WITH THE IMPELLA CP HEARTPUMP FOR OVER 24 HOURS.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT ON (B)(6) 2017 AN IMPELLA CP WAS PLACED IN A (B)(6) FEMALE PATIENT WHO HAD AN ACUTE MYOCARDIAL INFARCTION (AMI) AND WHO WAS IN CARDIOGENIC SHOCK (CGS). THE IMPELLA PUMP WAS PLACED IN THE PATIENT FOLLOWING THE PERFORMANCE OF A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PCI.) THE IMPELLA CP PLACEMENT WAS REPORTED TO HAVE BEEN "VERY VERY" DIFFICULT, AND TOOK 4 HOURS TO PLACE THE PUMP. THE PATIENT WAS SUPPORTED WITH THE IMPELLA CP FOR APPROXIMATELY 24 HOURS, BUT DURING THAT TIME PATIENT BLEEDING OCCURRED, AND IT WAS DECIDED TO REPLACE THE PUMP, WITH ANOTHER IMPELLA. THE REPLACEMENT IMPELLA CP WAS SUCCESSFULLY PLACED IN THE PATIENT, BUT BLEEDING CONTINUED. THE BLEEDING WAS THOUGHT TO BE COMING FROM THE BACK OF THE REPOSITIONING SHEATH, BUT CLOSER OBSERVATION BY THE CLINICIANS REVEALED THAT DAMAGE HAD OCCURRED TO THE HEMOSTATIC VALVE/ RING INSIDE THE REPOSITIONING SHEATH. THE CLINICIANS REPORTED THAT IT WAS ASSUMED THAT THE DAMAGE TO THE VALVE WAS DUE TO THE REPEATED IN AND OUT MOVEMENTS AND MANIPULATIONS OF THE IMPELLA CATHETER DURING INSERTION. AN ESTIMATED 2 LITERS OF PATIENT BLOOD WAS LOST, AND 7 BAGS OF REPLACEMENT PACKED RED BLOOD CELLS WERE ADMINISTERED TO THE PATIENT. THE PATIENT EXPIRED ON (B)(6) 2017 AS A RESULT OF MULTI-ORGAN FAILURE. THERE WAS NO INDICATION FROM THE PHYSICIAN THAT THE PATIENT OUTCOME WAS CAUSED OR CONTRIBUTED BY ANY ISSUE WITH THE IMPELLA CP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742174 IMPELLA CP TEMPORARY CARDIAC SUPPORT BLOOD PUMP OZD ABIOMED EUROPE GMBH IMPELLA CP 1282508 00813502011258

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention