BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 3953979 · Received July 23, 2014

    Report

    Report Number
    2024168-2014-04736
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS AND THE RESISTANCE WAS NOT NOTED USING A PROXY GUIDE WIRE; HOWEVER, COULD NOT BE TESTED WITH THE RETURNED WIRE DUE TO THE CONDITION. BASED ON A VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. IT SHOULD BE NOTED THAT THE ABSOLUTE PRO INSTRUCTION FOR USE (IFU) STATES: SHOULD UNUSUAL RESISTANCE BE FELT AT ANY TIME DURING LESION OR STRICTURE ACCESS OR DELIVERY SYSTEM REMOVAL, THE INTRODUCER SHEATH / GUIDING CATHETER AND STENT SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. APPLYING EXCESSIVE FORCE TO THE STENT DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND DELIVERY SYSTEM COMPONENTS. ALTHOUGH THE USE OF FORCE LIKELY CONTRIBUTED TO THE SEPARATION, THE DELIVERY SYSTEM COULD NOT BE REMOVED DUE TO BEING CAUGHT POSSIBLY ON THE STENT AND THEREFORE THE ADDITIONAL FORCE WAS REQUIRED. OVERALL, A CONCLUSIVE CAUSE FOR THE REPORTED RESISTANCE AND DIFFICULTY REMOVING COULD NOT BE DETERMINED; HOWEVER, THE SUBSEQUENT DAMAGE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT. THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). EXCESSIVE FORCE/AGAINST RESISTANCE. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS WAS AN UP AND OVER SUPERFICIAL FEMORAL ARTERY (SFA) STENTING PROCEDURE AT THE PROFUNDA/SFA BIFURCATION. PRE-DILATION WAS PERFORMED AND THE 5.0 X 40 MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED. THE STENT WAS DEPLOYED WITHOUT ISSUE. IMMEDIATELY FOLLOWING DEPLOYMENT, THE SESS WAS STUCK AND WOULD NOT MOVE WITHOUT MOVING THE STENT. SHORT SWIFT ADVANCEMENTS WERE MADE TO SEE IF THE SESS WOULD COME FREE. THE MAGNIFICATION WAS SIGNIFICANTLY INCREASED TO TRY AND DETERMINE WHERE THE STENT WAS GETTING STUCK, BUT IT COULD NOT BE DETERMINED. THERE WAS NO OBVIOUS POINT CAUSING THE PROBLEM. THE SESS WAS ROTATED OVER THE GUIDE WIRE A FEW TIMES WHILE ATTEMPTING TO GENTLY WITHDRAW THE DEVICE. EVENTUALLY A LITTLE MORE FORCE WAS APPLIED, AND THE SESS WAS REMOVED. ONCE THE SYSTEM EXITED THE ANATOMY, THERE WAS SIGNIFICANT RESISTANCE NOTED AS IT BECAME STUCK ON THE GUIDE WIRE. IT WAS FOUND THAT THE INNER PLASTIC LUMEN OF THE SESS HAD DETACHED FROM THE DEVICE AND WAS LAYERED OVER THE GUIDE WIRE. FORCEPS WERE USED TO HOLD THE PLASTIC LAYER AND THE GUIDE WIRE, THEN THE DEVICE WAS REMOVED. THE DISTAL PORTION OF THE GUIDE WIRE WAS STILL IN THE PATIENT ANATOMY WHEN THE FORCEPS WERE USED TO HOLD THE INNER LUMEN AND GUIDE WIRE, WHILE THE DELIVERY SYSTEM WAS REMOVED FROM THE GUIDE WIRE, AND THE PLASTIC WAS CUT FROM THE GUIDE WIRE. THE SYSTEM WAS NOT RETRACTED WITH THE GUIDE WIRE AS UNIT, AS THE PHYSICIAN DID NOT WANT TO LOSE WIRE ACCESS AS THERE WAS A SIGNIFICANT PORTION OF THE PROCEDURE THAT NEEDED TO BE COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432142 ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT 4032661

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE WIRE: ROSEN 0.035" 260CM