BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2223107 · Received August 25, 2011

    Report

    Report Number
    2024168-2011-05938
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 5, 2010
    Report Date
    August 2, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. REPORTED DEVICE (B)(4): INDICATION FOR USE. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA, RE-STENOSIS AND ISCHEMIA ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. IT WAS REPORTED THAT THE XIENCE STENT WAS IMPLANTED IN A RE-STENOSED LESION THAT HAD BEEN PREVIOUSLY STENTED. IT SHOULD BE NOTED THAT THE IFU STATES THAT THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (XIENCE V STENT) IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS. HOWEVER, IN THIS CASE, THE IMPLANTATION OF THE STENT TO TREAT IN-STENT RESTENOSIS DOES NOT APPEAR TO HAVE DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EFFECTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING AND THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 28 MONTHS AFTER THE XIENCE V STENTING OF A RE-STENOSIS IN THE MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY, THE PATIENT WAS HOSPITALIZED WITH CHEST PAIN RADIATING TO THE BACK AND ARM, REQUIRING REVASCULARIZATION. PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED ON 2 LESIONS, THE TARGET LESION AND A NON-TARGET VESSEL LESION. THE FUNCTIONAL ISCHEMIA TEST WAS POSITIVE, BUT CARDIAC ENZYMES AND ECG SHOWED NO MYOCARDIAL INFARCTION. THE SYMPTOMS RESOLVED AFTER THE INTERVENTION, AND THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR FILED (B)(6) 2011, NEW INFORMATION WAS RECEIVED THAT ON (B)(6) 2010, THE PATIENT EXPERIENCED CHEST PAIN. ON (B)(6) 2010, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION IN THE MID-LEFT ANTERIOR DESCENDING ARTERY. ECG ON (B)(6) 2010 SHOWED NO MYOCARDIAL INFARCTION. THE PATIENT'S SYMPTOMS RESOLVED AND SHE WAS DISCHARGED ON (B)(6) 2010. 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 8051361

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R