BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3130784 · Received May 24, 2013

    Report

    Report Number
    2024168-2013-03294
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 30, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    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. (B)(4): INDICATION FOR USE AND ABOVE THE RATED BURST PRESSURE. CONCOMITANT MEDICAL DEVICES: STENT: XIENCE V (2.75X18, 2.75X15, AND 2.75X12). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ANGINA AND STENOSIS/RESTENOSIS ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS. IT SHOULD BE NOTED THAT THE IFU STATES: XIENCE V IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO (NEW) NATIVE CORONARY ARTERY LESIONS. ADDITIONALLY, THE IFU STATES: DO NOT EXCEED THE LABELED RATED BURST PRESSURE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. THE XIENCE V REFERENCED IN IS BEING FILED UNDER SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2008, ONE XIENCE V STENT WAS IMPLANTED IN A LEFT ANTERIOR DESCENDING (LAD) ARTERY, ANOTHER XIENCE V STENT WAS IMPLANTED IN A DISTAL, LEFT CIRCUMFLEX (LCX) ARTERY, ANOTHER XIENCE V STENT WAS IMPLANTED IN A PROXIMAL LCX ARTERY, AND ANOTHER XIENCE V STENT WAS IMPLANTED IN A LEFT ATRIOVENTRICULAR BRANCH (LAV). APPROXIMATELY 4 YEARS, 5 MONTHS LATER, ON (B)(6) 2013, AT A FOLLOW UP VISIT, THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA. ON (B)(6) 2013, THERE WAS 60 % IN-STENT RESTENOSIS FOUND IN THE MID LAD (XIENCE V 2.75 X 12) AND A CUTTING BALLOON TECHNIQUE WAS DONE WITH IMPLANTATION OF A NON-ABBOTT STENT AS TREATMENT AND THERE WAS 65% IN-STENT STENOSIS FOUND IN THE DISTAL CX ARTERY (XIENCE V 2.75 X 18) AND A CUTTING BALLOON TECHNIQUE WAS DONE WITH IMPLANTATION OF TWO NON-ABBOTT STENTS AS TREATMENT. AN ANGIOGRAM FOUND 15% IN-STENT RESTENOSIS IN THE PROXIMAL CX ARTERY (XIENCE V 2.75 X 15) AND 10% IN-STENT RESTENOSIS FOUND IN THE OBTUSE MARGINAL (OM) ARTERY (XIENCE V 2.5 X 12). THERE WAS NO TREATMENT DONE ON THE PROXIMAL LCX OR THE OM ARTERIES. THE SYMPTOMS RESOLVED WITHOUT AN ADVERSE PATIENT SEQUELA ON (B)(6) 2013. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2013. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231663 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 7112741

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R