BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2770875 · Received October 3, 2012

    Report

    Report Number
    2024168-2012-06249
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 11, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: THE DEVICE WAS INITIALLY REPORTED AS RETURNING, BUT HAS NOW BEEN REPORTED AS NOT RETURNING BECAUSE IT WAS DISCARDED AT THE ACCOUNT. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. 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 THE PROCEDURE WAS TO TREAT A LESION IN THE MID TO DISTAL RIGHT CORONARY ARTERY WITH MILD TORTUOSITY AND MILD CALCIFICATION. THE 2.5 X 15 MM XIENCE V STENT DELIVERY SYSTEM (SDS) WAS INSPECTED AND APPEARED TO BE TIGHTLY CRIMPED ON THE BALLOON. PRE-DILATATION WAS PERFORMED AND THE XIENCE V SDS WAS ADVANCED TO THE LESION WITH SLIGHT RESISTANCE NOTED. DURING AN ATTEMPT TO DEPLOY THE STENT, THE STENT COULD BE SEEN DISLODGED FROM THE SDS. AN ATTEMPT WAS MADE TO RE-POSITION THE STENT, BUT THE STENT COULD NOT BE FOUND. A 2.75 X 15 MM XIENCE V SDS WAS USED TO TREAT THE LESION SUCCESSFULLY. THE PATIENT HAD AN OVERALL GOOD END RESULT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2030141

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Disability STENT: 2.75 X 15 MM XIENCE V