BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 3233031 · Received July 18, 2013

    Report

    Report Number
    2024168-2013-04508
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 24, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): AGAINST RESISTANCE, INCORRECT REMOVAL. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE STRETCHED SHAFT AND RESISTANCE WITH THE INTRODUCER SHEATH WERE UNABLE TO BE CONFIRMED. BASED ON A VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, 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. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. IT SHOULD BE NOTED THE ABSOLUTE PRO PERIPHERAL SELF EXPANDING STENT SYSTEM INSTRUCTIONS FOR USE 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.

    Description of Event or Problem · 1

    REPORTEDLY THE PHYSICIAN SUCCESSFULLY PLACED THE ABSOLUTE PRO STENT IMPLANT IN THE TARGET LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY VIA THE FEMORAL ARTERY WITH NO RESISTANCE FELT DURING ADVANCEMENT AND NO RESISTANCE FELT DURING STENT PLACEMENT. HOWEVER, RESISTANCE WAS FELT DURING REMOVAL INTO A NON-ABBOTT 6F SHEATH AND THE STENT DELIVERY SYSTEM (SDS) GOT STRETCHED. THE PHYSICIAN REPORTEDLY HAD TO APPLY STRONG FORCE ON THE SDS TO REMOVE IT OUT OF THE SHEATH AS A SINGLE UNIT. AFTERWARDS A SECOND ABSOLUTE PRO IN ANOTHER LESION WAS PLACED AS PLANNED AND WAS ADVANCED THROUGH THE SAME 6F SHEATH WHICH HAD BEEN KEPT IN PLACE WITHOUT ANY PROBLEMS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335746 ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT 2101161

    Patients

    Seq Age Sex Outcome Treatment
    1 SHEATH: CORDIS 6 F