BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM

    MDR report key: 2800544 · Received October 22, 2012

    Report

    Report Number
    2024168-2012-06672
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    September 28, 2012
    Report Date
    September 28, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). GUIDE WIRE: BOSTON SCIENTIFIC 3MM FIXED J; TERUMO ANGLED STUFF GLIDE. GUIDE CATH: 6FR BOSTON SCIENTIFIC IM (2); COOK AMPLATZ EXTRA STIFF STRAIGHT; ASAHI GRAND SLAM; ANGIODYNAMICS SIMMONS SIDEWINDER. RHV: COOK ANSEL SHEATH: 6FR 11CM MERIT PRECLUDE PRO. OTHER: SNARE DEVICE: AMPLATZ GOOSENECK; ENSNARE; ENCORE 26 ADVANTAGE KIT; EV3. TRAILBLAZER SUPPORT CATHETER (2) AGAINST RESISTANCE. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE STENT SEPARATION WAS ABLE TO BE CONFIRMED. THE DIFFICULTY DEPLOYING THE STENT AND DIFFICULTY REMOVING THE DEVICE 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. IT SHOULD BE NOTED THE ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM INSTRUCTIONS FOR USE STATES: SHOULD UNUSUAL RESISTANCE BE FELT AT ANY TIME DURING LESION ACCESS OR REMOVAL OF THE DELIVERY SYSTEM POST STENT IMPLANTATION, THE ENTIRE SYSTEM SHOULD BE REMOVED TOGETHER WITH THE INTRODUCER SHEATH OR GUIDING CATHETER AS A SINGLE UNIT. FAILURE TO FOLLOW THESE INSTRUCTIONS COULD RESULT IN FAILURE TO DEPLOY, DIFFICULTIES WITH DEPLOYMENT, PARTIAL STENT DEPLOYMENT OR DEPLOYMENT IN AN UNINTENDED LOCATION. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER PRE-DILATING THE LESION WITH A NON-ABBOTT BALLOON INFLATED TO 12 ATMOSPHERES FOR 45 SECONDS, AN 8.0X40X80 ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED WITHOUT RESISTANCE TO THE NON-CALCIFIED TARGET LESION IN THE NON-TORTUOUS LEFT PROXIMAL EXTERNAL ILIAC ARTERY. WHEN ATTEMPTING TO DEPLOY THE STENT, IT PARTIALLY DEPLOYED. BELIEVING THAT THE STENT HAD COMPLETELY DEPLOYED, THE PHYSICIAN WITHDREW THE ABSOLUTE PRO SESS FROM THE ANATOMY WITH SLIGHT RESISTANCE FELT. AFTER WITHDRAWAL, IT WAS DISCOVERED THAT THE STENT HAD SEPARATED WITH THE PROXIMAL PART OF THE STENT PARTIALLY PROTRUDING FROM THE RETRACTABLE SHEATH, AND THE DISTAL PART OF THE STENT REMAINING IN THE ANATOMY. AN ATTEMPT WAS MADE TO SNARE THE DISTAL STENT PIECE USING A NON-ABBOTT SNARE, BUT WAS UNSUCCESSFUL AND WAS WITHDRAWN. THE SEPARATED STENT WAS SUCCESSFULLY SNARED FROM THE ANATOMY USING A SECOND NON-ABBOTT SNARE. A NON-ABBOTT STENT WAS ADVANCED AND DEPLOYED, TREATING THE LESION, FOLLOWED BY POST-DILATATION WITH NON-ABBOTT BALLOONS. THERE WERE NO ADVERSE PATIENT SEQUELAE, HOWEVER, THIS ISSUE CONTRIBUTED TO A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM NIO AV-TEMECULA-CT 2011461

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention CONCOMITANT MEDICAL DEVICES