BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION?

    MDR report key: 3064435 · Received April 17, 2013

    Report

    Report Number
    2134265-2013-02798
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TARGET LESION # 1 WAS A CHRONICALLY OCCLUDED LESION LOCATED IN THE MID LAD WITH 100% STENOSIS AND WAS 25 MM LONG. THE TARGET LESION # 1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 MM X 28 MM ION US COA STENT. THE TARGET LESION # 2 WAS A DE NOVO LESION LOCATED IN THE DISTAL LAD WITH 80% STENOSIS AND WAS 28 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. THE TARGET LESION # 2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 MM X 32 MM ION US COA STENT WITH 0% RESIDUAL STENOSIS. THERE WERE TWO SEPARATE TARGET LESION IN MID AND DISTAL LAD RESPECTIVELY, CORRECTED FROM ONE LESION WITH STENTS PLACED OVERLAPPING. THERE WAS 60% FOCAL RESTENOSIS OF THE PREVIOUSLY PLACED STUDY STENT IN THE MID LAD WITH 0% RESIDUAL STENOSIS AND 75% STENOSIS LOCATED IN THE PROXIMAL LAD.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2013-02740, 2134265-2013-02799, 2134265-2013-02742, 213425-213-02739 AND 2134265-2013-02738. SAME PATIENT AS MDR ID#: 2134265-2013-02221, 2134265-2013-02751, 2134265-2013-02219, 2134265-2013-02218, 2134265-2013-02217, 2134265-2013-02216, 2134265-2013-01970. (B)(4). IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, ANGINA OCCURRED. IN (B)(6) 2012, CORONARY ANGIOGRAPHY REVEALED DE NOVO LONG LESION EXTENDING FROM MID LEFT ANTERIOR DESCENDING TO DISTAL LEFT ANTERIOR DESCENDING ARTERIES. THE LESION WAS 100% STENOSED AND WAS 58 MM. LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM AND WAS TREATED WITH PRE DILATION AND PLACEMENT OF 2.25 MM X 32 MM AND 2.50 MM X 28 MM ION STENTS IN AN OVERLAPPING MANNER. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL THE NEXT DAY. TWELVE DAYS LATER, THE PATIENT UNDERWENT ANGIOGRAPHY AND IT REVEALED 95% STENOSED LESION LOCATED IN THE SAPHENOUS VEIN GRAFT TO THE PROXIMAL RIGHT CORONARY ARTERY AND WAS 33MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF 3.00 MM X 38 AND 3.00 MM X 16 MM ION STENTS IN AN OVERLAPPING MANNER. RESIDUAL STENOSIS WAS 0%. FOLLOWING THE PLACEMENT, THERE WAS A TRANSIENT NO FLOW AND WAS TREATED WITH IC NITROGLYCERINE. THE NEXT DAY THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2013, THE PATIENT PRESENTED WITH SUBSTERNAL CHEST TIGHTNESS WHICH WAS NON RADIATING AND WAS HOSPITALIZED ON THE SAME DAY. 50-70% RESTENOSES WAS NOTED IN THE PREVIOUSLY PLACED STENTS IN THE MID LEFT ANTERIOR DESCENDING EXTENDING TO THE PROXIMAL LEFT ANTERIOR DESCENDING. THE LESION WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 3.5 MM X 28 MM PROMUS ELEMENT PLUS DES WITH RESIDUAL STENOSIS OF 0%. AFTER DEPLOYMENT OF THE 3.5 MM X 28 MM PROMUS ELEMENT PLUS STENT AND POST DILATION USING A NC QUANTUM APEX BALLOON, CHEST PAIN WAS NOTED AND WAS TREATED WITH FENTANYL AND NITRO. ON THE SAME DAY, THE EVENT WAS RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166129 ION? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902316300 14812746

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention