BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4190277 · Received October 21, 2014

    Report

    Report Number
    2024168-2014-06860
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 14, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 ANALYSIS. THE STENT DAMAGE WAS NOT CONFIRMED. HOWEVER, THERE WAS FOREIGN MATERIAL (STRING) IN THE INFLATION LUMEN. BASED ON A VISUAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. A QUERY/REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKAGING OF THE 2.5X28MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS), THE STENT IMPLANT WAS NOTED TO HAVE A FLARED STRUT AND THE SDS WAS NOT USED. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. AN UNSPECIFIED SDS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. THE XIENCE PRIME SDS WAS RETURNED WITH THE SHAFT TORN AND SEPARATED. FOLLOW-UP INFORMATION RECEIVED FROM THE ACCOUNT STATED THAT NO SEPARATION WAS REPORTED DURING USE OF THE DEVICE AND THAT IT MUST HAVE OCCURRED DURING SHIPPING/PACKAGING FOR RETURN. ADDITIONALLY, THE XIENCE PRIME SDS WAS RETURNED WITH A FOREIGN MATERIAL (STRING) IN THE INFLATION LUMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668309 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 112084X

    Patients

    Seq Age Sex Outcome Treatment
    1