BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2840684 · Received November 20, 2012

    Report

    Report Number
    2024168-2012-07331
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 30, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE PHYSICAL RESISTANCE AND DIFFICULTIES DEPLOYING THE STENT COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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 REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION. PRE-DILATATION WAS PERFORMED AND THE 2.75 X 8 MM XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION, WITH SOME RESISTANCE NOTED. THE STENT WAS DEPLOYED AT AN UNKNOWN PRESSURE AND THE SDS WAS PULLED BACK. AN INJECTION WAS MADE TO DETERMINE IF THE STENT WAS DEPLOYED, AND THE STENT WAS SEEN PARTIALLY DEPLOYED, AND HANGING IN THE VESSEL. THE PATIENT WAS SENT TO BY-PASS SURGERY FOR TREATMENT OF THE LESION AND REMOVAL OF THE STENT. THE PATIENT WAS REPORTED TO BE DOING GOOD AFTER SURGERY. 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 2020741

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S