BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 6535472 · Received May 1, 2017

    Report

    Report Number
    1220648-2017-00028
    Event Type
    Injury
    Date Received
    May 1, 2017
    Date of Event
    April 4, 2017
    Report Date
    April 6, 2017
    Manufacturer
    ABIOMED, INC
    Product Code
    OZD
    UDI-DI
    00813502011258
    PMA / PMN Number
    P1400003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 14FRENCNH INTRODUCER AND THE DILATORS USED WITH THE IMPELLA CP PUMP DURING THIS EVENT WERE RETURNED FOR ANALYSIS. UPON RECEIPT OF THESE DEVICES AN INITIAL INSPECTION WAS PERFORMED. THIS INSPECTION REVEALED MULTIPLE SPLITS ALONG THE LENGTH OF THE INTRODUCER SHEATH; IN ADDITION, THERE WAS NOTICEABLE DAMAGE TO EACH OF THE DILATOR TIPS. THE SHEATH WAS EXAMINED UNDER MAGNIFICATION AND CONFIRMED THAT THE SPLITS OCCURRED ALONG SCORE-LINES. THE DILATORS WERE ALSO EXAMINED UNDER MAGNIFICATION, AND THE MAGNIFICATION REVEALED THAT EACH DILATOR TIP WAS NICKED OUTWARD. THIS TYPE OF DAMAGE IS INDICATIVE OF CALCIFICATION/PERIPHERAL VASCULAR DISEASE (PVD) OCCLUDING THE INSERTION PATH. A REVIEW OF THE PATIENT CLINICAL NOTES WRITTEN BY THE PHYSICIAN CONFIRMED PVD. THE PVD LIKELY CAUSED THE SHEATH SPLITTING. THE INTRODUCER "PACEKENGED" INTO THIS KIT HAD BEEN INSPECTED AND HAD PASSED ALL INSPECTION CRITERIA. IN CONCLUSION, THE ROOT CAUSE OF THE PATIENT BLEEDING WAS A RESULT OF THE SPLITTING THAT OCCURRED ALONG MULTIPLE SCORE-LINES OF THE INTRODUCER, AND THAT THE PATIENT'S PVD LIKELY CONTRIBUTED TO THE SHEATH SPLITTING. A CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS 14FR INTRODUCER SHEATH FAILURES OF THIS KIND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2017, A (B)(6) YEAR OLD MALE PATIENT WAS BEING TREATED AT THE HOSPITAL. THE PATIENT WAS REPORTED TO HAVE A HISTORY OF AORTIC STENOSIS, SEVERE 3 VESSEL DISEASE, AND PERIPHERAL VASCULAR DISEASE WITH RIGHT SUPERFICIAL FEMORAL ARTERY COMPLETE OCCLUSION AND ILIAC CALCIFICATION. THE PATIENT HAD BEEN BROUGHT TO THE FACILITY FOR A RIGHT CORONARY ARTERY (RCA) AND LEFT MAIN ATHERECTOMY AND PERCUTANEOUS CORONARY INTERVENTION (PCI.) THE PHYSICIAN CHOSE TO PERFORM THE RCA INTERVENTION PRIOR TO IMPELLA CP. DURING THE MID RCA INTERVENTION THE VESSEL WAS DISSECTED REQUIRING SERIAL STENT DEPLOYMENT. POST PCI RCA, THE PATIENT PRESENTED WITH THROMBOLYSIS IN MYOCARDIAL INFARCTION PROFUSION GRADE 2. AN ANGIOGRAM OF THE RIGHT FEMORAL ARTERY (RFA) WAS PERFORMED USING A 6FR SHEATH SHOWING APPROPRIATE VESSEL SIZE AND PUNCTURE LOCATION. THE PHYSICIAN REPORTED THAT THE OSCOR SHEATH WAS INSERTED WITHOUT RESISTANCE USING ABIOMED 0.035 WIRE. AFTER THE OSCOR SHEATH WAS INSERTED THE PATIENT'S BLOOD PRESSURE DROPPED TO THE 50'S AND THE PATIENT BECAME BRADYCARDIC. CPR WAS STARTED. AN ANGIOGRAM REVEALED THAT THE OSCOR SHEATH HAD SPLIT DISTALLY, SHOWING RIGHT ILIAC DISSECTION AND STAINING SUGGESTING THE VESSEL HAD BEEN PERFORATED. THE OSCOR SHEATH WAS REMOVED OVER THE WIRE, AND THE PHYSICIAN ATTEMPTED THE INSERTION OF A 14 X 30 COOK SHEATH BUT WAS NOT ABLE TO DO SO DUE TO TORTUOSITY. AT THAT POINT VESSEL WAS CLOSED USING THE 2 EXISTING PERCLOSES. THE PATIENT WAS ADMINISTERED 6 UNITS OF REPLACEMENT BLOOD PRODUCTS AND WAS PUT ON SUPPORT USING CONTRALATERAL GROIN PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOONING TO REMEDY THE ISSUE; BESIDES RT ILIAC PTA AND MANUAL COMPRESSION NO OTHER INTERVENTION WAS NECESSARY OR PERFORMED TO ACHIEVE HEMOSTASIS AND THE PATIENT BECAME STABLE. THE PCI OF THE LEFT MAIN (LM) WAS THEN PERFORMED. AN ECHO CONFIRMED THAT CORRECT IMPELLA CP CANNULA POSITIONING HAD BEEN ACHIEVED AND RIGHT VENTRICLE (RV) CONTRACTILITY WAS ALSO CONFIRMED. NO HEMATOMA/BLEEDING OCCURRED AND DISTAL PULSES WERE CONFIRMED. THE PATIENT SUPPORT WAS REPORTED AS SUCCESSFUL, THERE WERE NO FURTHER ADVERSE EFFECT TO THE PATIENT AS A RESULT OF THE OSCOR SHEATH SPLITTING AND VENTRICLE PERFORATION. THE PATIENT SUBSEQUENTLY EXPIRED, THE FACILITY'S HEART TEAM STAFF DOES NOT BELIEVE THE IMPELLA CP CONTRIBUTED TO THE PATIENT EXPIRING, SINCE THE BLEEDING WAS CONTROLLED AND BLOOD WAS GIVEN TO REPLACE LOSS. THE PHYSICIAN RELATED THAT THE PATIENT OUTCOME WAS MOST LIKELY DUE TO THE RIGHT CORONARY LOW FLOW STATE POST PCI, WHICH WAS PERFORMED PRIOR TO THE INITIAL IMPLANT ATTEMPT AND INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315883 IMPELLA CP TEMPORARY CARDIAC SUPPORT BLOOD PUMP OZD ABIOMED, INC IMPELLA CP 1266569 00813502011258

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention