BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2210731 · Received August 12, 2011

    Report

    Report Number
    2024168-2011-05702
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    August 18, 2010
    Report Date
    July 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. THE REPORTED PATIENT EFFECTS OF ANGINA AND RESTENOSIS, AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY THIRTY SEVEN MONTHS POST XIENCE V STENTING PROCEDURE IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH ONE 3.0 X 18 MM STENT AND IN THE PROXIMAL RCA WITH ONE 3.0 X 18 MM STENT, THE PATIENT WAS HOSPITALIZED WITH ANGINA PECTORIS AND SHORTNESS OF BREATH. ON (B)(6) 2010, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION IN THE MRCA INDEX LESION WITH BALLOON ANGIOPLASTY AND IMPLANTATION OF A DRUG ELUTING STENT. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2010 AND THE PATIENT WAS DISCHARGED THE SAME DAY. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. 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 70228P6

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R STENT: XIENCE V 3.0 X 18 MM