BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA RP US HDE PUMP SET US

    MDR report key: 6119035 · Received November 21, 2016

    Report

    Report Number
    1220648-2016-00031
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    August 31, 2016
    Report Date
    August 31, 2016
    Manufacturer
    ABIOMED, INC
    Product Code
    OJE
    UDI-DI
    00813502010022
    PMA / PMN Number
    H140001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, WITH THE EXCEPTION OF THE DETACHED PORTION OF THE CANNULA, HAS BEEN RETURNED FOR EVALUATION; THE EVALUATION IS CURRENTLY BEING PERFORMED. UPON THE COMPLETION OF THE EVALUATION OF THE IMPELLA RP A SUPPLEMENTAL MEDWATCH REPORT CONTAINING THE RESULTS AND CONCLUSIONS WILL BE SUBMITTED. RESOLVED. (B)(4).

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT THEY WERE TREATING A VERY LARGE PATIENT WITH SIGNIFICANT AMOUNTS OF ADIPOSE TISSUE BETWEEN THE VEIN AND SKIN. THIS PATIENT HAD KNOWN CARDIAC DISEASE AND WAS IN THE HOSPITAL FOR MITRAL VALVE REPAIR. ON (B)(6) 2016 AN IMPELLA 5.0 WAS PLACED IN THE PATIENT FOR LEFT SIDE SUPPORT. ON (B)(6) 2016 IT WAS DETERMINED THAT THE PATIENT WAS IN NEED OF ESCALATED SUPPORT DUE TO RIGHT VENTRICLE FAILURE; CONSEQUENTLY, AN IMPELLA RP WAS ALSO PLACED. ACCESS AND PLACEMENT OF THE RP WAS DONE IN THE USUAL FASHION. PUMP FLOWS WERE NOT OPTIMAL DUE TO AN EXTREMELY LOW PULSATILITY AND LOW MEAN ARTERIAL PRESSURES. TO AUGMENT SUPPORT AND IMPROVE FLOW THE PATIENT RECEIVED MULTIPLE TRANSFUSIONS OF RED BLOOD CELLS (PRBC), PLASMA (FFP), AND ALBUMIN. FLOWS IMPROVED, AS DID MEAN ARTERIAL PRESSURE. THE PHYSICIAN CHOSE NOT TO REMOVE THE OSCOR PEEL AWAY SHEATH AT THIS TIME, SO THAT THEY WOULD HAVE ARTERIAL ACCESS SHOULD THE PATIENT REQUIRE ESCALATION OF CARE WITH AN ECMO AT A LATER TIME. THE PATIENT WAS THEN DISCHARGED TO THE ICU FOR CARE. IN THE OVERNIGHT, THE PATIENT WAS MONITORED TO SEE IF MORE BLOOD AND VOLUME WOULD BE NEEDED. THE CHEST TUBES WERE ALSO MONITORED FOR OUTPUT, AND THE PATIENT DID DEMONSTRATE PROGRESS ON SUPPORT. THE IV MEDICATIONS WERE ABLE TO BE WEANED DOWN. DUE TO THIS FACT, THE TEAM DECIDED TO PEEL AWAY THE OSCOR SHEATH AND TO POSITION THE IMPELLA RP'S REPOSITIONING SHEATH, AS AN ECMO WAS NO LONGER FELT TO BE NECESSARY. THE PATIENT WAS PROVIDED DIALYSIS DURING THE DAY FOR VOLUME CONTROL. DURING THE SECOND DAY THE PATIENT DEMONSTRATED IMPROVEMENT & WAS PROVIDED WITH DIALYSIS. DURING THE SECOND EVENING OF IMPELLA RP SUPPORT, THE PUMP FLOWS WERE REDUCING. MORE VOLUME WAS GIVEN IN THE FORM OF PRBCS AND ALBUMIN. UNFORTUNATELY, FLOWS DID NOT IMPROVE AND THE PATIENT WAS DETERIORATING WITH RISING LACTATE NUMBERS (LDH), AND WAS BECOMING COAGULOPATHIC AND ACIDOTIC. THE TEAM ALSO PERFORMED A CHEST X-RAY TO CONFIRM PROPER POSITION WITHIN THE RIGHT VENTRICLE. BECAUSE THE PUMP WAS IN THE PROPER POSITION, THE DECISION WAS MADE TO EXPLANT THE IMPELLA RP. UPON EXPLANT, THERE WAS RESISTANCE FELT BY THE PHYSICIAN. UPON INSPECTION IT WAS DISCOVERED THAT THE PUMP HAD COME APART INTO TWO PIECES, WITH THE PUMP AND MOTOR PORTION REMAINING LODGED IN THE FEMORAL VEIN. AS THE PATIENT WAS AT RISK WITH THE COAGULOPATHY TO UNDERGO A SURGICAL REMOVAL OF THE RP, THE TEAM DECIDED TO WAIT UNTIL THE PATIENT'S BLEEDING RISK IMPROVED. WHILE THE TEAM WAS AWAITING AN IMPROVEMENT IN THE BLEEDING RISK, THE PATIENT'S FAMILY CHOSE TO WITHDRAW THE PATIENT'S CARE. THE PATIENT EXPIRED AND THE DETACHED PORTION OF THE RP CANNULA REMAINS WITHIN THE PATIENT POST-MORTEM.

    Additional Manufacturer Narrative · 1

    THE IMPELLA RP WAS RETURNED WITHOUT THE CANNULA, AS THE CANNULA WAS APPARENTLY DISCARDED SUBSEQUENT TO USE. A VISUAL INSPECTION OF THE RETURNED PORTION OF THE DEVICE WAS PERFORMED. THE INSPECTION REVEALED THAT THE DELO ADHESIVE HAD FILLED THE ETCHINGS OF THE LASER-ETCHED BONDING SURFACE, BUT THERE WAS MINIMAL ADHESIVE COVERAGE OVER THE REST OF THE SURFACE. THE EVALUATION OF THE RETURNED PORTION OF THE IMPELLA RP REVEALED THAT THE PUMP MOST LIKELY SEPARATED DURING EXPLANT DUE TO THE PRESSURE APPLIED AT THE VENOUS ACCESS SITE AND THE STEEP INSERTION ANGLE REQUIRED BY THE PATIENT'S SIZE. THE PATIENT HAD BEEN REPORTED BY THE COMPLAINANT AS VERY LARGE, AND WITH SIGNIFICANT AMOUNTS OF ADIPOSE TISSUE BETWEEN THE VEIN AND THE PATIENT'S SKIN. MANUAL PRESSURE IS APPLIED DURING EXPLANT FROM ARTERIAL SITES, AND NOT AS REGULARLY AT VENOUS SITES. THE LEVEL OF PRESSURE APPLIED WAS INCREASED DUE TO THE DEPTH OF THE FEMORAL VEIN DUE TO THE PATIENT'S SIZE. THE DEPTH OF THE PATIENT'S VEIN WOULD ALSO REQUIRE A STEEPER INSERTION ANGLE. THE INCREASED LOAD REQUIRED TO EXPLANT THE CATHETER AGAINST THE MANUAL PRESSURE THROUGH THE SHARP ANGLE OF VENOUS ACCESS MAY HAVE CAUSED THE FAILURE OF THE DELO ADHESIVE JOINT, WHICH CAUSED THE CANNULA TO DETACH FROM THE PUMP. THE ROOT CAUSE OF THE CANNULA DETACHMENT WAS MOST LIKELY THE LOAD CREATED BY THE STEEP INSERTION ANGLE AND HIGH MANUAL PRESSURE APPLIED DURING EXPLANT DUE TO THE PATIENT'S SIZE. CORRECTIVE ACTION: A CAPA WAS OPENED TO ADDRESS RP CANNULA DETACHMENTS. FAILURES OF THIS TYPE WILL CONTINUE TO BE MONITORED AND TRACKED. (B)(4) SUPPLEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768391 IMPELLA RP US HDE PUMP SET US RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE OJE ABIOMED, INC IMPELLA RP US HDE PUMP SET 1212833 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    0 63 YR
    1 63 YR IMPELLA 5.0, S/N (B)(4)