BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1907971 · Received November 24, 2010

    Report

    Report Number
    2024168-2010-02550
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    April 2, 2010
    Report Date
    November 4, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE XIENCE V 1009541-12 LOT#8071561 IS BEING FILED UNDER A SEPARATE MFR#.

    Additional Manufacturer Narrative · 1

    (B)(6). ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. 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.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT THE INDEX PROCEDURE ON (B)(6) 2008, IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY THAT WAS 90% STENOSED AND IN THE PROXIMAL CIRCUMFLEX THAT WAS ALSO 90% STENOSED. THE TARGET LESIONS WERE PREDILATED AND THE STENTS WERE SUCCESSFULLY DEPLOYED AND WERE POSTDILATED. ON (B)(6) 2010, THE PATIENT EXPERIENCED EXERTIONAL CHEST, NECK AND JAW DISCOMFORT ALWAYS AFTER EATING, THAT RESOLVED WITH REST. THERE ARE NO REST SYMPTOMS. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2010 AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION OF BOTH TARGET LESIONS THAT WERE TREATED AT THE INDEX PROCEDURE. MEDICATION WAS ALSO ADMINISTERED. THERE WAS NO INDICATION OF A MYOCARDIAL INFARCTION. THE PATIENT SYMPTOMS RESOLVED ON (B)(6) 2010 AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION FROM THEIR DEVICE, AS WELL AS "SPASMS" IN THE DEVICE POCKET AREA AND LEGS. IT WAS STATED THAT PALPATING THE AREA CAUSED THE SPASMS TO STOP TEMPORARILY, BUT THEY RETURNED. IT WAS STATED THE SYMPTOMS HAD BEEN OCCURRING FOR "SEVERAL MONTHS." ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 8051262

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention