BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2931816 · Received January 28, 2013

    Report

    Report Number
    2024168-2013-00433
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE STENT DISLODGEMENT WAS CONFIRMED. THE REPORTED DIFFICULTY/RESISTANCE REMOVING THE PROTECTIVE SHEATH COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON VISUAL AND DIMENSIONAL ANALYSIS OF THE RETURNED STENT IMPLANT, STYLET AND PROTECTIVE SHEATH, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. 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 WHILE PREPPING A 3.0X33 RX XIENCE PRIME STENT DELIVERY SYSTEM (SDS) TO TREAT A LONG LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, THE STENT COMPLETELY DISLODGED FROM THE BALLOON WHEN REMOVING THE PROTECTIVE BALLOON SHEATH; REPORTEDLY, THE SHEATH MUST HAVE BEEN "TIGHT" DURING REMOVAL. THE PHYSICIAN HAD ALSO PLANNED TO USE A 3.0X15 RX XIENCE PRIME SDS TO TREAT A LESION IN THE DIAGONAL CORONARY ARTERY, HOWEVER, AS THE PHYSICIAN HAD PLANNED TO USE THE 3.0X15 SDS TO OVERLAP THE 3.0X33 RX XIENCE PRIME STENT, AND THE 3.0X33 STENT WAS NOT USED, THOUGH THE 3.0X15 PACKAGING HAD BEEN OPENED, THE PHYSICIAN DECIDED ALSO NOT TO USE THE 3.0X15 SDS DUE TO THIS CHANGE IN PLANS, AND SUBSEQUENTLY DISCARDED THE UNUSED 3.0X15 SDS. NEITHER DEVICES WERE USED IN THE PATIENT AND A 3.0X38 AND A 2.75X23 RX XIENCE PRIME SDS WERE USED TO TREAT THE LAD AND DIAGONAL LESIONS, RESPECTIVELY. THERE WAS NO PATIENT INVOLVEMENT AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36551 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2080741

    Patients

    Seq Age Sex Outcome Treatment
    1