BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2073347 · Received May 1, 2011

    Report

    Report Number
    2024168-2011-03055
    Event Type
    Injury
    Date Received
    May 1, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. TWO CINE COMPACT DISCS (CDS) WERE RETURNED AND REVIEWED BY AN ABBOTT CLINICAL SPECIALIST. DURING REVIEW OF THE FIRST CD, THE CLINICAL SPECIALIST NOTED TWO DISCRETE LESIONS IN THE CALCIFIED RIGHT CORONARY ARTERY (RCA): ONE IN THE PROXIMAL VESSEL AND ONE IN THE MID VESSEL. THE LESION AREAS WERE PRE-DILATED AND TWO STENTS WERE DEPLOYED, FOLLOWED BY POST-DILATATION. THE SECOND CD SHOWED A SUB-TOTAL OCCLUSION IN THE MID-RCA (THERE IS DISTAL FLOW). THE REVIEWER CONCLUDED THAT THE IMAGES CONFIRM THAT THERE WAS A SUB-TOTAL OCCLUSION IN THE AREA OF STENTS IMPLANTED IN THE RCA. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A 100% VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL (Q.C.) AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. THE 3.0 X 28 MM XIENCE V IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY ONE YEAR POST PLACEMENT OF TWO XIENCE V STENTS IN THE PROXIMAL RIGHT CORONARY ARTERY, THE PATIENT REPORTED CHEST PAIN. A STRESS TEST WAS POSITIVE, BUT MYOCARDIAL INFARCTION WAS RULED OUT. ON (B)(6) 2011, PER ANGIOGRAPHY, THE TWO XIENCE STENTS WERE NOTED TO BE OCCLUDED. THERE WAS NO TREATMENT PROVIDED. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED IN STABLE CONDITION. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION 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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| S XIENCE V 3.0 X 28 MM