BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 2193538 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05565
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    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 ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS RETURNED WITH BLOOD ON THE SHAFT, STENT IMPLANT AND ON THE HANDLE, CONSISTENT WITH THE REPORTED USE. THERE WAS NO SALINE VISIBLE. THE STENT IMPLANT WAS STATIONARY ON THE STENT HOLDER. THE STENT HOLDER AND DISTAL SHEATH WAS SEPARATED FROM THE SHAFT AS REPORTED. THE DISTAL AND PROXIMAL ENDS OF THE DISTAL SHEATH WERE TORN AND THE PROXIMAL END OF THE STENT WAS PARTIALLY EXPANDED 1.2 CM. THERE WERE EXPOSED AND BROKEN STRUTS ON THE FIRST ROW EXTENDED FROM THE DISTAL END OF THE TORN DISTAL SHEATH. THERE WAS A BEND IN THE MIDDLE END OF THE STENT IMPLANT. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT IMPLANT. THE STENT HOLDER WAS SMASHED PROXIMAL TO THE TIP. THE INNER MEMBER I-BEAM WAS RETURNED PULLED COMPLETELY OUT OF THE SHAFT. THERE WERE MULTIPLE BENDS IN THE ENTIRE LENGTH OF THE INNER MEMBER I-BEAM. THERE WAS A KINK IN THE SHAFT 2 MM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS NO OTHER DAMAGE NOTED TO THE SESS. THE HANDLE LOCK WAS IN THE UNLOCKED POSITION. AFTER OPENING THE HANDLE OBSERVED THE RACK WAS FULLY RETRACTED IN THE PROXIMAL POSITION. THERE WAS NO DAMAGE NOTED TO THE INTERNAL MECHANISMS. FACTORS THAT MAY CONTRIBUTE TO DIFFICULTY DEPLOYING THE STENT INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING; PRE DILATATION STRATEGY, ANATOMICAL CONDITIONS, DEPLOYMENT TECHNIQUE AND/OR DAMAGE TO THE DEVICE DEPLOYMENT MECHANISMS (HANDLE COMPONENTS/SHAFT LUMENS). IN THIS CASE, IT WAS REPORTED THAT THE LESION SITE WAS HEAVILY STENOSED AND CALCIFIED, AND THAT RESISTANCE WAS NOTED ADVANCING THE ABSOLUTE PRO TO THE LESION. IT MAY BE POSSIBLE THAT THE DISTAL END OF THE ABSOLUTE PRO BECAME LODGED WITHIN THE TIGHT CALCIFIED LESION IN SUCH THAT DURING THE ATTEMPT TO DEPLOY THE STENT, THE SHEATH COULD NOT BE FULLY RETRACTED. AS A RESULT, ONLY THE DISTAL END OF THE STENT PARTIALLY DEPLOYED LEAVING THE PROXIMAL PORTION STILL SHEATHED. IT SHOULD BE NOTED THAT THE ABSOLUTE PRO INSTRUCTIONS 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 A CONCLUSIVE CAUSE FOR THE DIFFICULTY DEPLOYING AND PARTIAL DEPLOYMENT COULD NOT BE DETERMINED, THE SUBSEQUENT DAMAGE TO THE DEVICE APPEARS TO BE DUE TO THE ATTEMPT TO PULL BACK THE STENT SYSTEM WITH FORCE AGAINST RESISTANCE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. ADDITIONALLY, THE LOT RELEASE TESTING RESULTS WERE REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. DURING PRODUCTION ALL SELF EXPANDING STENTS ARE 100% VISUALLY INSPECTED ON BOTH THE INNER DIAMETERS AND OUTER DIAMETERS FOR DAMAGE. ADDITIONALLY, THE STENTS ARE 100% INSPECTED AFTER THE STENT HAS BEEN COLLAPSED ONTO THE STENT HOLDER. ALL SELF EXPANDING STENT DELIVERY SYSTEMS ARE ALSO INSPECTED FOR DAMAGE DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: GLIDE WIRE. GUIDE CATH: C1. ROTATING HEMOSTATIC VALVE: TUOHY BORST. SHEATH: 6 FR ANL1 45 CM. OTHER: HEPARIN 5000 UNITS. DEVICE (B)(4) EXCESSIVE FORCE, AGAINST RESISTANCE, AND 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 ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE HEAVILY STENOSED AND CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA), RESISTANCE WAS MET ADVANCING A NON-ABBOTT GUIDE CATHETER WHICH WAS EXCHANGED FOR A NON-ABBOTT HYDROPHILIC CATHETER. ONCE THE GUIDE CATHETER HAD ADVANCED BEYOND THE LESION, PRE-DILATATION WAS NOT PERFORMED. THE PHYSICIAN STATED THAT THERE HAD NEVER BEEN AN ISSUE DEPLOYING THE STENT WITHOUT PRE-DILATATION. THE ABSOLUTE PRO STENT SYSTEM WAS ADVANCED TO THE LESION WITH RESISTANCE. STENT DEPLOYMENT WAS INITIATED BY TURNING THE THUMBWHEEL OF THE STENT SYSTEM AND THE PHYSICIAN FELT A DISTINCT STOP OF THE THUMBWHEEL. AN ATTEMPT WAS MADE TO PULL BACK THE STENT SYSTEM AND RESISTANCE WAS FELT. IMAGES REVEALED THAT THE DISTAL END OF THE STENT WAS EXPANDED; HOWEVER, THE REMAINDER OF THE STENT APPEARED TO BE NARROW (PARTIAL STENT DEPLOYMENT). THE PHYSICIAN ATTEMPTED TO PULL ON THE STENT SYSTEM BACK INTO THE SHEATH, AGAINST THE WARNING OF THE AV CLINICAL SPECIALIST WHO WAS PRESENT IN THE PROCEDURE. THE PHYSICIAN CONTINUED TO PULL ON THE STENT SYSTEM WHICH APPEARED TO BE CAUGHT ON THE PARTIALLY DEPLOYED STENT. THE OUTER SHEATH, HANDLE AND HYPOTUBE SEPARATED FROM THE TIP OF THE STENT DELIVERY SYSTEM. APPROXIMATELY 7CM OF THE HYPOTUBE REMAINED IN THE ANATOMY. AN UNSUCCESSFUL ATTEMPT WAS MADE TO SNARE THE SEPARATED SEGMENT. CUT DOWN AND REPAIR OF THE ARTERY (UNDER GENERAL ANESTHETIC) WAS REQUIRED TO RETRIEVE THE SEPARATED SEGMENT, CAUSING A SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. A NEW ABSOLUTE STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION AFTER PRE-DILATATION OF THE SFA. THE PATIENT WAS DISCHARGED (B)(6) 2011 WITH GOOD PULSES IN THE RIGHT LEG AND IS REPORTED TO BE FINE. NO ADDITIONAL INFORMATION WAS 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 0062151

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R