BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER

    MDR report key: 1373811 · Received May 1, 2009

    Report

    Report Number
    1820334-2009-00219
    Event Type
    Injury
    Date Received
    May 1, 2009
    Date of Event
    April 2, 2009
    Report Date
    April 2, 2009
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT EVALUATION: THE DEVELOPMENT OF THIS PRODUCT SUCCESSFULLY COMPLETED ALL VERIFICATION AND VALIDATION ACTIVITIES SHOWING THE DEVICE MEETS THE DESIGN REQUIREMENTS AND THAT THE DESIGN REQUIREMENTS MEET THE NEEDS OF THE USER. EACH DEVICE IS SHIPPED WITH AN "INSTRUCTION FOR USE" (IFU) BOOKLET DESCRIBING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. A COOK SALES REP. WAS PRESENT AT THE TIME OF THE PROCEDURE AND PROVIDED INFORMATION FOR THE CASE FILE. THE TESTIMONY OF THE SALES REP. IS ENOUGH CORROBORATING EVIDENCE TO CONSIDER THE COMPLAINT CONFIRMED AT THIS TIME. THE DEVICE REMAINS IMPLANTED AND NO IMAGES WERE PROVIDED TO ASSIST IN THIS INVESTIGATION. UNFORTUNATELY, WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE. HOWEVER, WE HAVE NOTIFIED THE APPROPRIATE INDIVIDUALS AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IN 2009, THE PHYSICIAN WAS ATTEMPTING TO PLACE A RENU CONVERTER ON A PT WHOSE LEFT ILIAC WAS COMPLETELY CLOSED OFF. THE PHYSICIAN THEN PLACED A RENU CONVERTER DOWN INTO THE RIGHT ILIAC AND EXTENDED THE ILIAC WITH A FLEX LEG. HOWEVER, DURING THE FINAL RUN, CONTRAST WAS SHOOTING OUT FROM WHAT APPEARED TO BE A FABRIC TEAR BETWEEN THE FIRST AND SECOND STENTS OF THE RENU CONVERTER (1820334-2009-00218). AFTER TURNING THE C-ARM MANY DIFFERENT WAYS AND RE-BALLOONING THE PROXIMAL NECK, THE FABRIC TEAR WAS STILL APPARENT. A CONVERTER WAS USED TO LINE THE RENU CONVERTER TO SEAL THE FABRIC TEAR. THE ENDOLEAK DISAPPEARED. HOWEVER, A SMALL LEAK APPEARED ON THE LEFT SIDE OF THE SCREEN THAT WAS NOT THERE PREVIOUSLY. THE PHYSICIAN BELIEVED THE LEAK FROM THE TEAR WAS GONE AND THERE HAD IN FACT BEEN A TEAR IN THE RENU'S FABRIC. THE PHYSICIAN WANTED TO PLACE ANOTHER CONVERTER TO MAKE SURE THERE WERE NO ENDOLEAKS SINCE THE PT WAS ON ANTICOAGULANTS. HOWEVER, NO OTHER CONVERTER WAS AVAILABLE. THE PHYSICIAN DECIDED TO PUT A CUFF PROXIMALLY. THE REP. WAS AGAINST THIS PROCEDURE BECAUSE OF THE SMALL DIAMETER, BUT SINCE THE NECK WAS COVERED WITH TWO PREVIOUS LAYERS OF STENTS AND FABRIC, THE PHYSICIAN THOUGHT IT WOULD BE OKAY. THE PHYSICIAN PUT A WIRE THROUGH THE RENAL TO ENSURE THAT IT WOULD NOT BE COVERED AND DEPLOYED ANOTHER MANUFACTURER'S CUFF RESOLVING THE ENDOLEAK. BASED ON THE INFORMATION IN THE CASE FILE, THE PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 1926981

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R