BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 6494382 · Received April 14, 2017

    Report

    Report Number
    1220648-2017-00024
    Event Type
    Injury
    Date Received
    April 14, 2017
    Date of Event
    March 16, 2017
    Report Date
    March 17, 2017
    Manufacturer
    ABIOMED, INC
    Product Code
    OZD
    UDI-DI
    00813502011258
    PMA / PMN Number
    P1400003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPELLA CP AT ISSUE IN THIS EVENT WAS RETURNED TO THE MANUFACTURER FOR EVALUATION; ALTHOUGH THE AUTOMATIC IMPELLA CONTROLLER DATA LOGS WERE ALSO RETURNED FOR ANALYSIS, DATA LOG REVIEW WAS NOT PERFORMED AS A REVIEW WAS NOT RELEVANT TO THIS FAILURE INVESTIGATION. DURING THE EVALUATION OF THE RETURNED IMPELLA CP A TEAR WAS FOUND ON THE END OF THE 9FR VYGON SHEATH. NO OTHER ISSUES OR DEFORMITIES WERE FOUND WITH THE PUMP. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED. THE REVIEW REVEALED THAT THERE WERE NO ISSUES OR REWORK RELEVANT TO THE FAILURE MODE AND NONE WERE DOCUMENTED ON THE DHR. THE 9 FRENCH REPOSITIONING VYGON SHEATH WAS PART OF BATCH 7052802, AND IT PASSED INCOMING INSPECTION. THOSE UNITS HAD ALSO BEEN VISUALLY AND GEOMETRICALLY INSPECTED. ALL INSPECTED UNITS PASSED INSPECTION. IN ADDITION, A REVIEW OF THE COMPLAINT DATA BASE REVEALED NO OTHER COMPLAINTS HAVE BEEN FILED FOR OTHER PUMPS FROM LOT NUMBER 1272918 OR FOR OTHER 9 FR VYGON SHEATHS FROM BATCH 7052802. (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT ON (B)(6) 2017, A (B)(6) MALE SUFFERING FROM AN ACUTE MYOCARDIA INFARCTION AND IN CARDIOGENIC SHOCK WAS DETERMINED TO BE IN NEED OF IMPELLA CP SUPPORT. AN ANGIOGRAPHY WAS PERFORMED ON THE PATIENT'S RIGHT FEMORAL ARTERY USING A 6FR SHEATH PRIOR TO 14FR OSCOR SHEATH INSERTION. THE PHYSICIAN CONFIRMED ADEQUATE VESSEL SIZE AND THE ABSENCE OF VESSEL TORTUOSITY OR CALCIFICATION. THE RIGHT FEMORAL ARTERY PUNCTURE LOCATION WAS CONSIDERED APPROPRIATE. THE VESSEL WAS SEQUENTIALLY DILATED. ACCORDING TO THE PHYSICIAN THE 14FR OSCOR WAS INSERTED OVER THE ABIOMED 0.035" GUIDEWIRE WITHOUT ANY RESISTANCE OR DIFFICULTY. NO UNUSUAL BLEEDING WAS OBSERVED AND THE IMPELLA CP WAS INSERTED THROUGH THE OSCOR SHEATH WITHOUT ISSUE, THE PUMP WAS STARTED, AND THE OSCOR SHEATH WAS PEELED AWAY. THE REPOSITIONING SHEATH WAS FLUSHED AND INSERTED ALSO WITHOUT DIFFICULTY, THEN SUTURED IN PLACE, AND THE CATHETER WAS SECURED. TEGADERM WAS APPLIED COVERING THE ENTRY SITE. NO UNUSUAL BLEEDING OR HEMATOMA WAS NOTED BY THE CATH LAB STAFF. THE PHYSICIAN REPORTED THAT THERE WAS ONLY A MINOR OOZE WHICH WAS EXPECTED. THE PATIENT WAS TRANSFERRED TO THE ICU. THE PATIENT'S ACT AT THIS TIME WAS 185. AFTER BEING IN THE ICU FOR AN HOUR, A NURSE NOTED MODERATE OOZING AROUND THE REPOSITIONING SHEATH. MANUAL PRESSURE WAS APPLIED FOR 30 MINUTES. NO HEMATOMA WAS NOTED. THE OOZE PROGRESSED TO A MILD BLEEDING, AND THE BLEEDING WAS CONTROLLED USING A FEMOSTOP. THE NURSE STATED THE PRESSURE ON THE FEMOSTOP CONTROLLER WAS SET TO 20 MMHG BELOW THE PATIENT'S SYSTOLIC PRESSURE. APPROXIMATELY 30 MINUTES LATER THE NURSE REPORTED HIGH PURGE ALARMS, TROUBLE SHOOTING WAS UNABLE TO DETERMINE THE CAUSES FOR THE ALARMS. IT WAS THEN THOUGHT THAT THE EXCESSIVE FEMOSTOP PRESSURE COULD BE CAUSING AN OBSTRUCTION IN THE CATHETER, THUS LEADING TO HIGH PURGE PRESSURE. THE NURSE REPOSITIONED THE FEMOSTOP, AND THE HIGH PURGE PRESSURE ALARM WAS RESOLVED. AFTER REPOSITIONING THE FEMOSTOP, MILD BLEEDING RETURNED REQUIRING MORE ADJUSTMENTS. THE NURSE WAS ABLE TO STOP THE BLEEDING, AND STATED THAT THE PATIENT RECEIVED ONE UNIT OF REPLACEMENT BLOOD, NO HEMATOMA WAS SEEN. THE FOLLOWING MORNING THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL TO BE EVALUATED FOR A POSSIBLE HEART TRANSPLANT. UPON ARRIVAL ACTIVE BLEEDING WAS NOTED FROM THE IMPELLA SITE. THE PHYSICIAN AND NURSE RELATED THAT BLEEDING WAS NOTED BY THE TRANSPORT TEAM PRIOR TO THE PATIENT LEAVING THE FIRST HOSPITAL. THE ESTIMATED BLOOD LOSS WAS REPORTED TO BE AT LEAST 2 LITERS. THE STAFF AT THE TRANSFER FACILITY ATTEMPTED TO REMOVE THE FEMSTOP, BUT THE BLEEDING BECAME PULSATILE AND EXCESSIVE. THE PHYSICIAN ORDERED THAT THE ANTICOAGULANT BE REVERSED, AND AFTER TWO HOURS THE FEMSTOP WAS REMOVED. BLEEDING WAS STILL AN ACTIVE PULSATILE BLEED AND WAS THEN CONTROLLED WITH MANUAL PRESSURE. AFTER 15 MINUTES OF MANUAL PRESSURE, THE DOCTOR LIGHTENED PRESSURE AND BLEEDING RESUMED. THE IMPELLA SITE WAS ASSESSED AND THE REPOSITIONING SHEATH WAS FOUND TO BE IN THE PROPER POSITON, SUTURED WITH NO ACUTE ANGLES OR ISSUES. THE FEMSTOP WAS PLACED BACK ON THE PATIENT. VASCULAR SURGERY AND CARDIOLOGY WERE BOTH CONSULTED AND THE DECISION WAS MADE TO REMOVE THE IMPELLA CP. THE PUMP WAS THEN SUCCESSFULLY WEANED AND REMOVED FROM THE PATIENT. THE PHYSICIAN HELD PRESSURE AND HEMOSTASIS WAS ABLE TO BE ACHIEVED. PATIENT SUPPORT WAS DEEMED SUCCESSFUL; THERE WERE NO ADDITIONAL ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274951 IMPELLA CP TEMPORARY CARDIAC SUPPORT BLOOD PUMP OZD ABIOMED, INC IMPELLA CP 1272918 00813502011258

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention