BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM

    MDR report key: 3173335 · Received June 17, 2013

    Report

    Report Number
    2024168-2013-03774
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT PRODUCTS: GUIDE WIRE: TERUMO 180, TERUMO STIFF 180; GUIDE CATH: 0.018 SV 8 CORDIS; SHEATH: TERUMO 6F, TERUMO DESTINATION 45 CM. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE ADDITIONAL ABSOLUTE PRO LL REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE DIFFICULTY DEPLOYING THE STENT WAS ABLE TO BE CONFIRMED; HOWEVER, THE STENT SEPARATION WAS UNABLE TO BE CONFIRMED AS THE STENT REMAINS IN THE PATIENT ANATOMY. THE PHYSICAL RESISTANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE HEAVILY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE COMMON FEMORAL ARTERY (CFA) WAS PREDILATED. SUB-INTIMAL RECANALIZATION WAS PERFORMED AT THE SFA FROM THE ORIGIN TO THE HUNTER. PRE-DILATATION WAS PERFORMED ON THE SFA. THE RESULT WAS NOT ADEQUATE WITH IMAGES SHOWING DISSECTIONS. A 7 X 150 ABSOLUTE PRO STENT WAS ADVANCED WITH RESISTANCE TO THE PROXIMAL PART OF THE SFA. DURING THE ATTEMPT TO DEPLOY THE STENT THE HANDLE STUCK AND THE STENT WAS NOT DEPLOYED. THE STENT DELIVERY SYSTEM (SDS) WAS RETRACTED AND 2 CM OF THE STENT IMPLANT WAS OBSERVED TO BE DEPLOYED AND THE HANDLE SEEMED TO HAVE RELEASED. A SECOND 7 X 150 ABSOLUTE PRO WAS INSERTED TO BE PLACED AT THE LOWER SFA; HOWEVER, CROSSING WAS DIFFICULT DUE TO CALCIFICATION. DURING THE ATTEMPT TO DEPLOY THE STENT THE THUMBWHEEL STUCK, DEPLOYING 2 CM OF THE STENT. THE HANDLE OPENED AND THE WHEEL TURNED FREELY WITHOUT RESISTANCE WITHOUT RELEASING THE STENT. AN ATTEMPT WAS MADE TO RETRACT THE SDS; HOWEVER, THE STENT IMPLANT SEPARATED LEAVING 2 CM OF THE STENT IN THE ARTERY AT THE HUNTER LEVEL. DURING RETRACTION OF THE SDS, THE REMAINING PART OF THE STENT WAS RELEASED FROM THE SHEATH INTO THE LONG INTRODUCER LOCATED AT THE EXTERNAL ILIAC ARTERY (IA). WHEN ATTEMPTING TO RETRIEVE THE DEVICE; THE PROXIMAL PART OF THE STENT SLIPPED FROM THE INTRODUCER SHEATH INTO THE ARTERY. ANOTHER LONG INTRODUCER WAS POSITIONED TO INSERT AND DEPLOY A NON-ABBOTT 7 X 120 STENT IN THE PROXIMAL SFA. A 5 X 60 XPERT STENT WAS SUCCESSFULLY DEPLOYED AT THE CFA. THE ABSOLUTE PRO STENT PART LOCATED IN THE EXTERNAL IA WAS COMPRESSED INTO THE ARTERY WALL WITH A BALLOON TO SECURE IT IN THE ARTERY. THE PATIENT'S CONDITION IS GOOD AND THE RIGHT ARTERY TRACT IS PERMEABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274510 ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT 3012361

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention