BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY¿

    MDR report key: 5204211 · Received November 5, 2015

    Report

    Report Number
    2134265-2015-07402
    Event Type
    Injury
    Date Received
    November 5, 2015
    Date of Event
    October 2, 2015
    Report Date
    October 9, 2015
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT UNSTABLE ANGINA AND IN-STENT RESTENOSIS (ISR) OCCURRED. IN (B)(6) 2014, THE PATIENT PRESENTED WITH OBJECTIVE EVIDENCE OF SILENT ISCHEMIA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. A DAY AFTER, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH 80% STENOSIS AND WAS 23 MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. THE TARGET LESION WAS TREATED WITH PRE DILATATION AND PLACEMENT OF A 28X3.00MM STUDY STENT WITH 0% RESIDUAL STENOSIS. TWO DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ACETYLSALICYLIC ACID AND CLOPIDOGREL. IN (B)(6) 2015, THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA. FOUR DAYS LATER, THE PATIENT WAS HOSPITALIZED. TWO DAYS POST-HOSPITALIZATION, DIAGNOSTIC ANGIOGRAPHY REVEALED 80% ISR IN THE PREVIOUSLY PLACED STUDY STENT IN THE DISTAL RCA. THIS WAS TREATED WITH PERCUTANEOUS CORONARY INTERVENTION (PCI). FOLLOWING INTERVENTION, RESIDUAL STENOSIS WAS 0%. FOUR DAYS POST PROCEDURE, THE EVENT WAS CONSIDERED TO BE RECOVERED/RESOLVED AND THE PATIENT WAS DISCHARGED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735424 SYNERGY¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493919828300 15992416

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R