BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION¿

    MDR report key: 2895365 · Received January 3, 2013

    Report

    Report Number
    2134265-2012-08239
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    June 2, 2012
    Report Date
    December 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATION 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

    SAME PATIENT AS MDR ID#2134265-2012-08181. SAME CASE AS MDR ID# 2134265-2012-08238. (B)(4). IT WAS REPORTED THAT POST A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. IN (B)(6) 2012, THE PATIENT PRESENTED WITH SUBSTERNAL CHEST PAIN RADIATING THE ARMS, JAWS AND WAS SUBSEQUENTLY DIAGNOSED WITH UNSTABLE ANGINA. ON ADMISSION, EKG REVEALED NON Q WAVE MI AND TROPONIN VALUES WERE ELEVATED. THE 90% STENOSED AND 8MM LONG DE-NOVO FIRST TARGET LESION WAS LOCATED IN THE MID SAPHENOUS VEIN GRAFT TO RIGHT POSTERIOR DESCENDING ARTERY WITH A REFERENCE VESSEL DIAMETER OF 3.00MM. THE FIRST TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00X16MM ION US COA STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE 60% STENOSED AND 3MM LONG DE-NOVO SECOND TARGET LESION WAS LOCATED IN THE PROXIMAL SAPHENOUS VEIN GRAFT TO RIGHT POSTERIOR DESCENDING ARTERY WITH A REFERENCE VESSEL DIAMETER OF 8.00MM. THE SECOND TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF A 3.00X16MM ION US COA STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE FOLLOWING DAY THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE PATIENT PRESENTED WITH CHEST PAIN RADIATING TO LEFT ARM, JAW AND WAS HOSPITALIZED ON THE SAME DAY. ON ADMISSION, EKG REVEALED ELEVATED CARDIAC ENZYMES AND ST ELEVATION MYOCARDIAL INFARCTION AND LEFT BUNDLE BRANCH BLOCK. THE PATIENT EXPERIENCED ISCHEMIC SYMPTOMS WITH RECURRENT CHEST PAIN LASTING FOR MORE THAN 20 MINUTES. CARDIAC CATHETERIZATION WAS RECOMMENDED. A NON-TARGET LESION LOCATED IN DISTAL LEFT CIRCUMFLEX ARTERY (LCX) WAS TREATED WITH PRE-DILATATION USING 3MM APEX QUANTUM BALLOON. A POSSIBLE DISSECTION WAS NOTED DURING THE TREATMENT OF THE LESION WHICH WAS TREATED WITH THE PLACEMENT OF 2.5MM NON BSC DRUG ELUTING STENT. THE FOLLOWING DAY THE EVENT WAS CONSIDERED AS RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE PATIENT PRESENTED WITH MIDSTERNAL CHEST PAIN, RETCHING RADIATING TO RIGHT JAW. THE PAIN IS CHARACTERIZED AS DULL AND SHARP AND SUBSEQUENTLY THE PATIENT¿S CARDIAC ENZYMES WERE FOUND TO BE ELEVATED AND THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. THE PATIENT EXPERIENCED ISCHEMIC SYMPTOMS WITH RECURRENT CHEST PAIN LASTING FOR MORE THAN 20 MINUTES. ECG CHANGES WERE INDICATIVE OF ISCHEMIA. THE PATIENT HAD A VENTRICULAR FIBRILLATION ARREST AND WAS DEFIBRILLATED WITH RETURN OF SPONTANEOUS CIRCULATION. EKG FINDINGS REVEALED 80 BEATS/MINUTE, LEFT BUNDLE BRANCH BLOCK AND NONSPECIFIC ST-T CHANGES. THE PATIENT WAS HOSPITALIZED ON THE SAME DAY AND WAS REFERRED FOR CARDIAC CATHETERIZATION. CORONARY ANGIOGRAPHY REVEALED THE TARGET VESSELS IN THE SAPHENOUS VEIN GRAFT TO RIGHT POSTERIOR DESCENDING ARTERY WERE THROMBOTICALLY OCCLUDED. THE TARGET LESION LOCATED IN SVG TO 1ST DIAGONAL WERE TREATED WITH PRE-DILATATION USING A 2MM MAVERICK BALLOON AND ASPIRATION OF A COPIOUS AMOUNT OF DENSE THROMBUS, RESULTING IN 0% RESIDUAL STENOSIS. THE FOLLOWING DAY THE EVENT WAS CONSIDERED AS RESOLVED WITHOUT RESIDUAL EFFECTS AND A FEW DAYS LATER THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3702 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902416300 14815985

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention