BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3113795 · Received May 15, 2013

    Report

    Report Number
    2134265-2013-03092
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    March 6, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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).

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM, THERAPY DATES AND DESC: UPDATED CORRECTION: DESCRIBE EVENT OR PROBLEM, DEVICE CODE FROM STENT BENT, DEVICE OR DEVICE COMP DAMAGED BY ANOTHER DEVICE TO NO KNOWN DEVICE PROBLEM. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT AFTER SIGNIFICANT SIDE BRANCH STENOSIS OCCURRED, THE PHYSICIAN PERFORMED KISSING BALLOON TECHNIQUE USING TWO NON-BSC BALLOONS, 2.5 X 15MM AND 2.0 X 15MM. IT WAS PREVIOUSLY REPORTED THAT STENT DEFORMATION OCCURRED BUT NOW IT IS REPORTED THAT NO STENT DEFORMATION OCCURRED. THE PHYSICIAN CONSIDERED THE STENT REACTION TO BE NORMAL, CAUSED BY THE USE OF KISSING BALLOON TECHNIQUE. INTRAVASCULAR ULTRASOUND (IVUS) CONFIRMED STENT EXPANSION AND FURTHER TREATMENT WAS NOT REQUIRED. CORONARY ANGIOGRAPHY REVEALED OVER DILATATION OF THE PROXIMAL STENT AND STENOSIS JUST DISTAL THE 2ND DIAGONAL, BUT THE PHYSICIAN COULD NOT RECOGNIZE STENOSIS ON IVUS.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, SIDE BRANCH STENOSIS INCREASED AND STENT DAMAGE OCCURRED. IN (B)(6) 2013, THE PATIENT PRESENTED WITH STABLE ANGINA (CCS CLASSIFICATION-2) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 75% STENOSED, 15 X 2.5MM TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE TARGET LESION WAS TREATED WITH PRE-DILATATION, PLACEMENT OF A 2.50 X 20 MM STUDY STENT, AND POST-DILATATION WITH 0% RESIDUAL STENOSIS. BASELINE CORE LAB ANGIOGRAPHY REVEALED 60% SIDE BRANCH STENOSIS AT 2ND DIAGONAL BRANCH WHILE POST PROCEDURE ANGIOGRAPHY REVEALED 75% 'BRANCH PERCENT STENOSIS' IN 2ND DIAGONAL BRANCH. DURING SIDE BRANCH TREATMENT, STENT DEFORMATION OCCURRED. THE PATIENT WAS DISCHARGED TWO DAYS LATER ON DUAL ANTIPLATELET THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214014 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911420250 15460884

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention ASAHI SION GUIDE WIRE| BALLOON CATHETER: LAXA 2.5X15MM| BALLOON CATHETER: LIFESPEAR 2.0X15MM| GOODMAN TGV3 PLUS SUPPORT FLOPPY