BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY¿

    MDR report key: 5202297 · Received November 4, 2015

    Report

    Report Number
    2134265-2015-07497
    Event Type
    Injury
    Date Received
    November 4, 2015
    Date of Event
    October 9, 2015
    Report Date
    October 13, 2015
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    BRAND NAME CORRECTED FROM SYNERGY BALLOON DILATATION CATHETER TO SYNERGY¿. COMMON DEVICE NAME CORRECTED FROM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL TO CORONARY DRUG-ELUTING STENT. UPN- SEARCH CORRECTED FROM UNK425 - SYNERGY - CMC - (B)(4) (PERIPHERAL INTERV) - 35000 TO UNK776 - SYNERGY II DES - CMC - (B)(4) (INTERVENT CARDIO) - 30000. UPN CORRECTED FROM UNK425 TO UNK776. PMA# OR 510K# CORRECTED FROM K993305 TO SIMILAR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DISLODGEMENT INSIDE THE PATIENT OCCURRED. A SYNERGY DRUG ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING PROCEDURE, THE STENT CAME OFF THE SHAFT AND EMBOLIZED. THE PROCEDURE WAS COMPLETED WITH A NON BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DISLODGEMENT INSIDE THE PATIENT OCCURRED. A SYNERGY DRUG ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING PROCEDURE, THE STENT CAME OFF THE SHAFT AND EMBOLIZED. THE PROCEDURE WAS COMPLETED WITH A NON BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732050 SYNERGY¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK776

    Patients

    Seq Age Sex Outcome Treatment
    1 Other