BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3180468 · Received June 20, 2013

    Report

    Report Number
    2024168-2013-03832
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. 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. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MILDLY TORTUOUS, MILDLY CALCIFIED, 90% STENOSED MID LEFT ANTERIOR DESCENDING ARTERY. PRE-DILATATION WAS PERFORMED PRIOR TO STENTING. AFTER SEVERAL ATTEMPTS TO CROSS THE LESION WITH THE 3.5X15 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS), DIFFICULTY WAS EXPERIENCED RETRACTING THE SDS. FEARING DISLODGEMENT OF THE STENT, THE STENT IMPLANT WAS DEPLOYED IN 60% OF THE DISEASED LESION AND PARTIALLY IN HEALTHY TISSUE. THE REMAINING 40% WAS TREATED WITH PLAIN OLD BALLOON ANGIOPLASTY SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279942 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2073141

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention