BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION?

    MDR report key: 3911996 · Received July 3, 2014

    Report

    Report Number
    2134265-2014-03758
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    December 21, 2013
    Report Date
    June 5, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WEIGHT: (B)(6). DEVICE IS A COMBINATION PRODUCT. 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).

    Description of Event or Problem · 1

    (B)(4) STUDY. IT WAS REPORTED THAT WEAKNESS, SLURRING OF SPEECH, STROKE AND TRANSIENT ISCHEMIC ATTACK (TIA) OCCURRED. IN (B)(6) 2011, THE INDEX PROCEDURE WAS PERFORMED. THE 99% STENOSED, 18X2.5MM, DE NOVO, TYPE C AND TIMI 1 FLOW TARGET LESION WAS LOCATED IN MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PHYSICIAN TREATED THE LESION WITH PREDILATATION OF A 2.0X 12MM NON-BSC BALLOON CATHETER AT 40 ATMOSPHERES FOR 24 SECONDS AND PLACEMENT OF A 20MM X 2.50MM ION¿ STENT RESULTING IN RESIDUAL STENOSIS OF 0% AND TIMI 3 FLOW. THE PATIENT WAS DISCHARGED ON PLAVIX 75MG AND ASPIRIN 81MG ONCE A DAY. ON (B)(6) 2013, THE PATIENT ADMITTED WITH COMPLAINT OF RIGHT HANDED WEAKNESS AND SLURRING OF SPEECH, HOWEVER, SIGNIFICANT OTHER STATES IT IS WITHIN NORMAL LIMITS (WNL). IT WAS NOTED THAT PATIENT WAS UNABLE TO PICK UP HIS CELLPHONE WHEN IT WAS DROPPED IN THE FLOOR. THE PATIENT DENIES ALTERED LEVEL OF CONSCIOUSNESS (ALOC) AND NUMBNESS/TINGLING. IT WAS NOTED THAT PATIENT RIGHT HANDED GRIP (PUSHES AND PULLS) WAS WEAK AND PATIENT'S ALERTNESS AND ORIENTATION SCORE WAS TIMES 4; NO FACIAL DROOP, PEDAL PUSHES, NO CHEST PAIN OR SHORTNESS OF BREATH WAS NOTED. AT THE TIME OF EVENT, PATIENT WAS ON ASPIRIN 81MG AND EFFIENT 10MG ONCE A DAY. SUBSEQUENTLY,CT SCAN OF THE BRAIN WAS PERFORMED AND REVEALED AREAS OF ACUTE INFARCT. PATIENT WAS THEN ADVISE FOR MAGNETIC RESONANCE IMAGING (MRI) FOR FURTHER EVALUATION. IN ADDITION, VOLUME LOSS WITH CHRONIC WHITE MASTER MICROVASCULAR ISCHEMIC CHANGE WAS NOTED AND NO INTRACRANIAL MASS OR SHIFT OR BLEED WAS IDENTIFIED. PATIENT WAS DIAGNOSED WITH TIA. NO TREATMENT WAS GIVEN BUT BED REST WAS OBSERVED. ONE DAY FROM ADMISSION, THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390446 ION? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902420250

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other BALLOON CATHETER: MINI TREK 2.0X12