BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPT¿

    MDR report key: 2870260 · Received December 12, 2012

    Report

    Report Number
    2134265-2012-08189
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIM
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM, THERAPY DATES AND DESC: ADDITIONAL INFORMATION.(B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. INITIAL REPORTER: DR. (B)(6). (B)(4). DEVICE EVALUATED BY MFR: 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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT DELIVERY SYSTEM BECAME STUCK ON THE GUIDE WIRE. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE STENOSED TARGET LESION WAS LOCATED IN THE HIGHLY TORTUOUS CAROTID ARTERY WHICH WAS NOTED TO HAVE A "LOOP" SHAPE. THE 40MM ADAPT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION WITHOUT ISSUE. WHEN THE PHYSICIAN ATTEMPTED TO RELEASE THE STENT, THE SHEATH OF THE DEVICE WOULD NOT RETRACT. THE SDS HAD BECOME STUCK ON THE GUIDE WIRE. THE TWO DEVICES WERE REMOVED TOGETHER AS A UNIT WITH THE STENT STILL CONTAINED WITHIN ITS SHEATH AND THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURER'S STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DEVICE WAS USED WITH A NON BSC EMBOLIC PROTECTION SYSTEM AND A NON BSC GUIDE CATHETER. PRE-DILATION WAS PERFORMED. THE NON BSC EMBOLIC PROTECTION SYSTEM WAS NOTED TO HAVE BEEN POSITIONED INSIDE THE PATIENT FOR APPROXIMATELY 5-10 MINUTES PRIOR TO ADVANCING THE ADAPT STENT SYSTEM OVER IT; RESISTANCE WAS FELT DURING ADVANCEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPT¿ STENT, CAROTID NIM BOSTON SCIENTIFIC - MAPLE GROVE M001552040

    Patients

    Seq Age Sex Outcome Treatment
    1 6F, COOK 90CM GUIDE CATHETER| ANGIOWARD EMBOLIC PROTECTION SYSTEM