BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION¿

    MDR report key: 3013285 · Received March 20, 2013

    Report

    Report Number
    2134265-2013-01462
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    January 7, 2013
    Report Date
    February 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: 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).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED CHEST PAIN AND ACUTE CORONARY SYNDROME. THE TARGET LESION WAS A DE-NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 80% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 2.50 MM X 20 MM ION STENT. THE STENT WAS DEPLOYED IN OVERLAPPING FASHION WITH PREVIOUSLY PLACED PROXIMAL NON-BSC STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO RECURRENT CHEST PAIN AND BACK PAIN AS A SQUEEZING SENSATION ASSOCIATED WITH LEFT ARM AND RIGHT ARM NUMBNESS WHICH WAS DIAGNOSED AS ACUTE CORONARY SYNDROME AND WAS HOSPITALIZED. THE PATIENT HAS AN ONGOING PROBLEM OF ARM PAIN WHICH WAS DIAGNOSED AS TENDINITIS. EKG DEMONSTRATED NONSPECIFIC ST-T WAVE CHANGES. THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION WHICH REVEALED 70%-80% RESTENOSIS AT DISTAL EDGES OF THE PREVIOUSLY PLACED STUDY STENT. AS TREATMENT THE PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFTING TIMES 2 WITH LEFT INTERNAL MAMMARY ARTERY TO THE LAD AND SAPHENOUS VEIN GRAFT TO THE DIAGONAL ARTERY. THE EVENT WAS CONSIDERED RESOLVED WITH RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116350 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902420250 14759293

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention