BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ GENESIS ON AMIIA

    MDR report key: 1901301 · Received November 17, 2010

    Report

    Report Number
    9610978-2010-00242
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A NON-STERILE PALMAZ GENESIS AMIIA 6.0MMX15MM WAS RECEIVED COILED INSIDE A BAG. THE DEVICE WAS RECEIVED SEPARATED IN TWO PIECES AT 114.4CM FROM HUB/STRAIN RELIEF; THE OTHER SEPARATED PIECE MEASURED 52CM, AND THIS PIECE WAS ELONGATED AT 38.7CM TO 52 CM. THE BALLOON APPEARS AS IF IT HAD BEEN INFLATED AND DEFLATED, AND ALSO PRESENTS RESIDUES OF CONTRAST MEDIA. NO OTHER ANOMALIES WERE NOTED. FUNCTIONAL TEST FOR GUIDEWIRE AND CSI INSERTION WERE DONE TO PERFORM DIMENSIONAL ANALYSIS. FOR THE DETACHED PIECE OF THE SDS, AN 0.014 GUIDEWIRE WAS INSERTED THROUGH THE GW LUMEN AND NO RESISTANCE WAS FELT. THEN THE DETACHED PORTION OF THE SDS WAS INSERTED INTO A 6F GUIDING CATHETER, WITH NO FRICTION OR RESISTANCE FELT. A SCANNING ELECTRON MICROSCOPE WAS PERFORMED ON THE RECEIVED UNIT, AND THE RESULTS SHOWED THAT THE SHAFT PRESENTED EVIDENCE OF TEARING AND ELONGATION IN THE DISTAL SURFACE, AS WELL AS ABRASIONS AND COMPRESSION. THE PROXIMAL SEPARATION SURFACE SHOWED EVIDENCE OF TEARING AND ELONGATION; THESE CHARACTERISTICS SUGGEST THAT PULLING OF THE UNIT TO FAILURE COULD BE RELATED TO THE SEPARATION (TENSILE OVERLOAD); HOWEVER, THE EXACT CAUSE OF THE SEPARATION COULD NOT BE CONCLUSIVELY DETERMINED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT; HOWEVER A PTHS WAS GENERATED IN ORDER TO WAIT FOR PRA APPROVAL, UNTIL PRA WAS APPROVED THE PTHS WAS CLOSED AND THE LOT WAS RELEASED. THIS PROCESS TO HOLD BARES NO RELATION TO THE COMPLAINT REPORTED. THE SDS SEPARATED IN PATIENT AND WITHDRAWAL DIFFICULTY FAILURES REPORTED BY THE COSTUMER WERE CONFIRMED; THE EXACT CAUSE FOR THE DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE DHR NOR THE ANALYSIS SUGGESTS THAT THIS KIND OF FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. AT THIS TIME THERE IS NOT ENOUGH INFORMATION TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. HOWEVER, THE PATIENT'S DIFFICULT ANATOMY AND PROCEDURAL MANIPULATION MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    WHILE REMOVING THE STENT DELIVERY SYSTEM AFTER SUCCESSFUL DIRECT STENTING OF A MODERATELY CALCIFIED AND TORTUOUS RIGHT RENAL ARTERY WITH A 70% STENOSIS, FRICTION/RESISTANCE WAS FELT. WHEN THE DEVICE WAS PULLED BACK WITH SLIGHT TENSION, THE SDS SHAFT WAS TORN AND SEPARATED. THE SDS WITH THE BALLOON REMAINED ON THE GUIDEWIRE AND WAS SAFELY REMOVED USING A SNARE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS ON AMIIA ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS EUROPA, N.V. NA 15105525

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TERUMO RUNTHROUGH PH .0.014" GUIDEWIRE