BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 2083620 · Received May 10, 2011

    Report

    Report Number
    2024168-2011-03363
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 15, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CINE IMAGES OF THE PROCEDURE WERE RETURNED AND REVIEWED BY AN ABBOTT CLINICAL SPECIALIST. THE REVIEW FURTHER SUGGESTS THAT A STENT FRACTURE MAY BE UNLIKELY. THE IMAGE RESULTS ARE AS FOLLOWS: BEFORE POST DILATION: THERE IS A STEP IN THE STENT CONTOUR AT MID LEVEL, AND A NARROWING OF THE STENT AT LITTLE MORE DISTAL. BOTH THESE PROJECTIONS ARE POSSIBLE WITH AN INTACT STENT. IT IS ASSUMED THAT THE PHYSICIAN INTERPRETS THE STEP IN THE STENT CONTOUR AS A FRACTURE. THE STENT IS IN A NORMAL POSITION AND NOT STRETCHED. THE IMAGE OF THE STENT CAN BE RECREATED WITH AN INTACT STENT; THE OPEN-CELLED ABSOLUTE STENT WOULD ACCOMMODATE TO A PLAQUE IN THE VESSEL WALL. AFTER POST DILATION: THE STENT LOOKS WELL EXPANDED THROUGHOUT; THERE IS NO INDICATION OF INTEGRITY LOSS. CONCLUSION: THE REPORTED STENT FRACTURE IS NOT SUPPORTED BY THE IMAGES PROVIDED. BASED ON THE CINE REVIEW, THERE IS NO INDICATION TO SUGGEST A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. USE OF A BILIARY STENT IN PERIPHERAL VASCULATURE THE STENT REMAINS INSIDE THE PATIENT. IT IS POSSIBLE THAT THE FRACTURED STENT APPEARANCE WAS RELATED TO THE STENTS OPEN CELL DESIGN AND ITS EXPANSION WITHIN THE PATIENT ANATOMY. UNDER FLUOROSCOPY, THE INDEPENDENT RING EXPANSION MAY APPEAR AS A STEP IN THE CONTOUR OF THE STENT AND MAY BE ERRONEOUSLY INTERPRETED AS A STENT FRACTURE. WITHOUT IMAGES TO REVIEW, THE REPORTED STENT FRACTURE COULD NOT BE VERIFIED AND IT IS POSSIBLE THAT THE STENTS FRACTURED APPEARANCE IS ANATOMICALLY RELATED; HOWEVER, THIS COULD NOT BE CONFIRMED. FACTORS THAT MAY CONTRIBUTE TO A FRACTURED STENT INCLUDE, BUT ARE NOT LIMITED TO, DAMAGED STRUTS, LOW RADIAL FORCE, STRETCHED STENT, FATIGUE, OR INTERACTION WITH OTHER DEVICES. DURING PRODUCTION ALL ABSOLUTE PRO STENTS ARE VISUALLY INSPECTED FOR STENT DAMAGE (BOTH THE INTERNALLY AND EXTERNALLY), DIMENSIONALLY MEASURED, AND ADIAL FORCE TESTED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS (LHR) DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS FOR THIS LOT AND THERE HAVE BEEN NO OTHER INCIDENTS FOR STENT FRACTURE REPORTED FOR THIS LOT. A CONCLUSIVE CAUSE OF THE REPORTED STENT FRACTURE COULD NOT BE DETERMINED. BASED ON THE LHR REVIEW AND SIMILAR INCIDENT RESULTS, THERE IS NO INDICATION TO SUGGEST A PRODUCT DEFICIENCY. THE ABSOLUTE PRO WAS USED TO TREAT THE SUPERFICIAL FEMORAL ARTERY, THE ABSOLUTE PRO INSTRUCTIONS FOR USE STATES THAT THE ABSOLUTE PRO .035 BILIARY SELF-EXPANDING STENT SYSTEM IS INTENDED FOR PALLIATION OF MALIGNANT STRICTURES IN THE BILIARY TREE. IT COULD NOT BE DETERMINED IF THE OFF-LABEL USE CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH REPORT, TWO CINE PICTURES OF THE PROCEDURE WERE RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEPLOYMENT OF THE ABSOLUTE PRO STENT IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA), THE STENT WAS VISUALIZED FRACTURING DURING DEPLOYMENT. THE PATIENT HAD LEG PAIN THAT RESOLVED WITH ADDITIONAL BALLOON DILATATION. THE PATIENT WAS ABLE TO WALK AFTER THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT 0111961

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention