BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2806977 · Received October 27, 2012

    Report

    Report Number
    2024168-2012-06810
    Event Type
    Death
    Date Received
    October 27, 2012
    Date of Event
    July 30, 2012
    Report Date
    October 1, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT ESTIMATED. DATE OF IMPLANT ESTIMATED. CONCLUSIONS: SF AFTER EVEROLIMUS-ELUTING STENT IMPLANTATION OCCURS IN 2.9% OF LESIONS AND IS ASSOCIATED WITH HIGHER RATE OF MAJOR ADVERSE CARDIAC EVENTS, DRIVEN BY HIGHER TARGET LESION REVASCULARIZATION AND STENT THROMBOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS CASE REPRESENTS A SUMMARY OF DEATH EVENTS. THE MALFUNCTIONS AND SERIOUS INJURIES CAPTURED WILL BE FILED UNDER SEPARATE MFR REPORT NUMBERS. THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON REVIEW OF THE ARTICLE, INCIDENCE AND CLINICAL IMPACT OF STENT FRACTURE AFTER EVEROLIMUS-ELUTING STENT IMPLANTATION. A TOTAL OF 1035 PATIENTS WITH 1339 LESIONS UNDERGOING EVEROLIMUS-ELUTING STENT IMPLANTATION AND FOLLOW-UP ANGIOGRAPHY 6 TO 9 MONTHS AFTER INDEX PROCEDURE WERE ANALYZED. SF WAS DEFINED AS COMPLETE OR PARTIAL SEPARATION OF THE STENT, AS ASSESSED BY PLAIN FLUOROSCOPY OR INTRAVASCULAR ULTRASOUND DURING FOLLOW-UP. WE ASSESSED THE RATES OF SF AND MAJOR ADVERSE CARDIAC EVENTS, DEFINED AS CARDIAC DEATH, MYOCARDIAL INFARCTION, STENT THROMBOSIS AND CLINICALLY DRIVEN TARGET LESION REVASCULARIZATION (TLR) WITHIN 9 MONTHS. SF WAS OBSERVED IN 39 OF 1339 LESION (2.9%) AND IN 39 OF 1035 PATIENTS (3.8%). OSTIAL STENT LOCATION AND LESIONS WITH HINGE MOTION, TORTUOSITY, OR CALCIFICATION WERE INDEPENDENT PREDICTORS OF SFS. THE RATE OF MYOCARDIAL INFARCTION AND TARGET LESION REVASCULARIZATION WERE SIGNIFICANTLY HIGHER IN THE SF GROUP THAN IN THE NON-SF GROUP (5.1% VERSUS 0.4%; P=0.018 AND 25.6% VERSUS 2.0%; P<0.0001, RESPECTIVELY). STENT THROMBOSIS WAS MORE FREQUENTLY OBSERVED IN THE SF GROUP THAN IN THE NON-SF GROUP (5.1% VERSUS 0.4%; P=0.018. MAJOR ADVERSE CARDIAC EVENTS WITHIN 9 MONTHS WERE SIGNIFICANTLY HIGHER IN THE SF GROUP THAN IN THE NON SF GROUP (25.6% VERSUS 2.3%; P<0.001). IT WAS NOTED THAT A CLINICALLY DRIVEN TLR WAS DEFINED AS TREATMENT FOR RECURRENT ANGINA PECTORIS BEFORE FOLLOW-UP ANGIOGRAPHY OR A >70% DIAMETER STENOSIS ON FOLLOW-UP ANGIOGRAPHY IN THE PRESENCE OF SIGNS OR SYMPTOMS OF MYOCARDIAL ISCHEMIA.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death