BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2955238 · Received February 11, 2013

    Report

    Report Number
    2024168-2013-00721
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 14, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED AND THE SEPARATION OF THE HYPOTUBE WAS CONFIRMED VIA RETURNED DEVICE ANALYSIS. THE REPORTED INFLATION ISSUE COULD NOT BE REPLICATED AS THE RETURNED DEVICE WAS NOT RETURNED IN A CONDITION IN WHICH THE TEST COULD BE PERFORMED. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND A REVIEW OF THE COMPLAINT HISTORY 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. 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 LOCATED IN THE MODERATELY TORTUOUS, PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. AFTER PRE-DILATION OF THE LESION WAS PERFORMED, THE 3.5X33 MM XIENCE PRIME STENT DELIVERY SYSTEM WAS POSITIONED IN THE TARGET LESION; HOWEVER, THE SDS BALLOON WOULD NOT INFLATE TO DEPLOY THE STENT. IT WAS OBSERVED THAT THE HYPOTUBE HAD SEPARATED IN TWO PIECES, WHICH WAS THE CAUSE OF THE FAILURE TO INFLATE. THERE WAS NO UNUSUAL RESISTANCE FELT CROSSING TO THE LESION PRIOR TO THE SEPARATION. ONLY 3 CM OF THE SDS REMAINED EXTERNAL TO THE Y CONNECTOR, WHICH WAS FIXED IN THE Y CONNECTER TO REMOVE IT. A 3.5X33 MM NON-ABBOTT STENT WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. 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
    58483 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 1082941

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR