BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2874473 · Received December 14, 2012

    Report

    Report Number
    2024168-2012-07975
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    May 27, 2012
    Report Date
    November 21, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA, MYOCARDIAL INFARCTION, AND RESTENOSIS ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS KNOWN PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA AND 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: THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO NATIVE CORONARY ARTERY LESIONS. 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

    RECEIVED NEW INFORMATION THAT ON (B)(4) 2012 THE PATIENT ALSO HAD CHEST PAIN AND TIGHTENING. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2012 AND AN ANGIOGRAM WAS DONE WITH A DIAGNOSIS OF A MYOCARDIAL INFARCTION OF THE TARGET VESSEL. THERE WERE ELEVATED TROPONIN AND CK-MB LEVELS. THERE WAS NO TREATMENT PROVIDED AND THE SYMPTOMS RESOLVED WITHOUT AN ADVERSE PATIENT SEQUELA ON (B)(6) 2012. THE PATIENT WAS DISCHARGED ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED THAT A CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY WAS DONE TO BYPASS THE TARGET VESSEL IN (B)(6) 2012 AS TREATMENT FOR AE3: ANGINA BEGINNING ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO XIENCE V STENTS WERE IMPLANTED IN A RESTENOSED, PROXIMAL, LEFT ANTERIOR DESCENDING (LAD) ARTERY AND APPROXIMATELY, 6 MONTHS LATER, ON (B)(6) 2012, THE PATIENT COMPLAINS OF EXPERIENCING TWO EPISODES OF CHEST PAINS [ANGINA] THAT PERSISTED FOR SEVERAL MINUTES ON A FOLLOW UP PHYSICIANS VISIT. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2012, AN ANGIOGRAM WAS DONE WITH FINDINGS OF TARGET VESSEL/TARGET LESION RESTENOSIS, AN ELECTROCARDIOGRAM (ECG) WAS DONE WITH NO FINDINGS OF A MYOCARDIAL INFARCTION (MI), AND A XIENCE V STENT PERCUTANEOUS INTERVENTIONAL PROCEDURE (PCI) WAS DONE ON THE PROXIMAL LAD, TARGET VESSEL/TARGET LESION OBTAINING COMPLETE REVASCULARIZATION. ON (B)(6) 2012, THE PATIENT HAD NORMAL CREATINE KINASE MUSCLE AND BRAIN (CK-MB) AND CREATINE KINASE (CK) ENZYMES, BUT ELEVATED TROPONIN ENZYME LEVELS. THE SYMPTOMS RESOLVED THREE DAYS LATER AND THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2012. APPROXIMATELY 11 MONTHS AFTER THE INDEX PROCEDURE, ON (B)(6) 2012 THE PATIENT COMPLAINED OF CHEST PAINS [ANGINA] AT A FOLLOW UP PHYSICIANS VISIT. THE PATIENT WAS AGAIN HOSPITALIZED ON (B)(6) 2012 AND THE ECG FOUND NO MI. A DIAGNOSTIC ANGIOGRAM WAS DONE ON (B)(6) 2012 IN THE PROXIMAL LAD, TARGET VESSEL/TARGET LESION WITH FINDINGS OF 99% INSTENT RESTENOSIS. ON (B)(6) 2012, THE PATIENT HAD NORMAL CK-MB ENZYME RESULTS, BUT ELEVATED TROPONIN ENZYME LEVEL. THE SYMPTOMS RESOLVED ON (B)(6) 2012 AND THE PATIENT WAS DISCHARGED HOME WITH A PLAN TO UNDERGO A BY-PASS SURGERY IN THE FUTURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND 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 1061643

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R| S STENT: XIENCE V 3.5 X 18