BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 2981189 · Received February 27, 2013

    Report

    Report Number
    2134265-2013-00972
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K993232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2013-00966, 2134265-2013-00968, 2134265-2013-01691. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, A INSTENT RESTENOSIS OCCURRED. THE PATIENT PRESENTED WITH INSTENT RESTENOSIS OF A PREVIOUSLY IMPLANTED WALLSTENT. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE 100% STENOSED CHRONIC TOTAL OCCLUSION TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE FIRST INFLATION OF A 1.5MM X 20MM X 143CM COYOTE ES MR BALLOON CATHETER AT 6 ATMS A BALLOON RUPTURE OCCURRED. THE COYOTE ES MR BALLOON CATHETER WAS REMOVED AND EXCHANGED FOR ANOTHER 1.5MM X 20MM X 143CM COYOTE ES MR BALLOON CATHETER. THE DISTAL END OF THE LESION WAS DILATED AT 6ATMS/30 SECONDS. WHEN THE SECOND COYOTE ES MR BALLOON CATHETER WAS MOVED TO THE PROXIMAL SIDE OF THE TARGET LESION RESISTANCE WAS ENCOUNTERED. THE COYOTE ES MR BALLOON CATHETER WAS REMOVED. IT WAS NOTED THAT THE GUIDE WIRE EXIT PORT WAS PARTIALLY DETACHED. A 2MM X 40MM X 145CM COYOTE ES MR BALLOON CATHETER WAS ADVANCED TO THE PROXIMAL SIDE OF THE TARGET LESION AND INFLATED TO 6ATMS. DURING THE SECOND INFLATION AT 6ATMS A BALLOON RUPTURE OCCURRED. THE COYOTE ES MR BALLOON CATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A 2MMX220MM COYOTE BALLOON CATHETER INFLATED TO 6ATMS, A 2.5MMX220MM COYOTE BALLOON CATHETER INFLATED TO 10ATMS/30SECONDS AND A 4MM SPCB INFLATED TO 6ATM/30 SECONDS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83593 WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY UNK479

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BALLOON CATHETER, 2MM X 40MM COYOTE ES MR| BALLOON CATHETER, 1.5MM X 20MM COYOTE ES MR| GUIDE WIRE, CRUISE 0.014INCH