BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRIUM ICAST COVERED STENTS

    MDR report key: 3960373 · Received July 17, 2014

    Report

    Report Number
    1219977-2014-00204
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    JCT
    PMA / PMN Number
    K050814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED STENT DELIVERY SYSTEM WAS REMOVED FORM THE BIO-HAZARD BAG AND INSPECTED. THE STENT WAS DISLODGED FROM THE BALLOON AND WAS PROXIMAL UP THE SHAFT TOWARD THE INFLATION MANIFOLD. THE STENT WAS IN THE CRIMPED POSITION AND SLIGHTLY FLARED ON BOTH ENDS AS IT HAD BEEN PUSHED UP AND OVER THE PROXIMAL BALLOON CONE. THE CENTER OF THE STENT WAS MEASURED USING CALIPERS AND FOUND TO BE 2.4MM. THIS DIAMETER IS INDICATIVE OF A PROPERLY CRIMPED STENT. THE BALLOON WAS IN GOOD CONDITION AND IN THE FOLDED POSITION. THE BALLOON WAS INSPECTED TO ENSURE THE WITNESS LINES OF THE CRIMPED STENT WERE VISIBLE. THE IMPRINTS OF THE STENT FRAME WERE CLEARLY VISIBLE AND ARE INDICATIVE OF A PROPERLY CRIMPED STENT. THE INTRODUCER SHEATH USED IN THE CASE WAS NOT RETURNED; THEREFORE, AN INSPECTION OF THE SHEATH DIMENSIONS OVERALL CONDITION COULD NOT BE ASSESSED (THIS IS IMPORTANT AS THE COMPLAINT DETAILS INDICATE THAT THE STENT WAS DISLODGED WHILE PASSING THROUGH THE HEMOSTASIS VALVE). A FULL REVIEW OF THE CATHETER LOT HISTORY RECORDS FOR THE DEVICE IN QUESTION WAS PERFORMED. THE RECORDS INDICATE THAT THIS LOT OF CATHETERS PASSED ATRIUM'S FINAL LOT QUALIFICATION TESTING. THIS INSPECTION REQUIRES THAT THE CATHETER LOT MUST PASS THE FOLLOWING: ABILITY OF THE STENT AND DELIVERY SYSTEM TO BE PASSED THROUGH THE LABELED INTRODUCER SHEATH. ABILITY TO DEPLOY THE STENT AND NOMINAL PRESSURE (8ATM). ABILITY TO WITHDRAW THE DEFLATED BALLOON CATHETER BACK THROUGH THE LABELED INTRODUCER SHEATH. ABILITY OF THE DELIVERY SYSTEM TO WITHSTAND 10 INFLATE/DEFLATE CYCLES AT THE RATED BURST PRESSURE (12ATM) WITHOUT LEAKS OR FAILURES. RESULT: ALL CATHETERS PASSED THIS FINAL INSPECTION. NO STENT DISLODGEMENTS WERE NOTED DURING THE PERFORMANCE TESTING AND ALL SAMPLES PASSED THROUGH THE INTRODUCER SHEATH WITHOUT A DISLODGEMENT OR DAMAGE. ENGINEERING SUMMARY/CONCLUSION: THE DETAILS OF THE COMPLAINT INDICATE THAT THE STENT WAS DISLODGED WHILE ATTEMPTING TO PASS THE STENT THROUGH A TIGHT LESION. IT IS POSSIBLE THAT THE LESION WAS OF A DIAMETER THAT WAS SMALLER THEN THE CRIMPED STENT OUTER DIAMETER OF THE I-CAST COVERED STENT. THIS COULD CAUSE THE STENT TO DISLODGE IF ENOUGH FORCE WAS GENERATED WHILE ATTEMPTING TO PASS THE STENT THROUGH THE LESION. CONCLUSION: BASED ON THE DETAILS OF THE REPORTED EVENT ATRIUM CAN FIND NO FAULT WITH THE DEVICE LOT IN QUESTION.

    Description of Event or Problem · 1

    DURING ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR CASE, A STENT CAME OFF THE BALLOON WHILE ATTEMPTING TO GO INTO 7FR X 55 RAABE SHEATH. THE PHYSICIAN FOLLOWING THE WIRE BACK VIA X-RAY WITH NO DETERMINATION OF STENT LOCATION. IT WAS ONLY WHEN THE PHYSICIAN LOOKED DOWN AT HIS SHEATH, THAT HE OBSERVED THAT THE STENT WAS ON THE WIRE AND HAD NOT CROSSED THE HEMOSTATIC VALVE. THE STENT WAS REMOVED AND A NEW ONE WAS SELECTED AND INSERTED WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420329 ATRIUM ICAST COVERED STENTS PROSTHESIS, TRACHEAL, EXPANDABLE JCT ATRIUM MEDICAL CORP. 85419 10902354

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention 0.035 X 300 ABBOTT SUPRA CORE| 7FR 55CM COOK RAABE INTRODUCER SHEATH