BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION?

    MDR report key: 3872441 · Received June 13, 2014

    Report

    Report Number
    2134265-2014-03341
    Event Type
    Death
    Date Received
    June 13, 2014
    Date of Event
    April 18, 2013
    Report Date
    May 21, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: 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

    SAME CASE AS MDR ID: 2134265-2014-03339; 2134265-2014-03340; 2134265-2014-03342; 2134265-2014-03439. (B)(4). IT WAS REPORTED THAT CARDIAC ARREST, MYOCARDIAL INFARCTION (MI) AND PATIENT DEATH OCCURRED. IN (B)(6) 2012, THE PATIENT WAS PRESENTED DUE TO STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE INDEX PROCEDURE WAS PERFORMED. TARGET LESION #1 WAS A RESTENOTIC LONG LESION LOCATED IN MID (RIGHT CORONARY ARTERY (RCA) EXTENDING TO DISTAL RCA WITH 100% STENOSIS AND WAS 38 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 MM X 38 MM ION¿ STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION #2 WAS A RESTENOTIC LESION LOCATED IN PROXIMAL RCA WITH 100% STENOSIS AND WAS 24 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 MM X 24 MM ION¿ STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE PATIENT RETURNED TO THE CATHETERIZATION LAB FOR A STAGED PROCEDURE. ANGIOGRAPHY REVEALED SAPHENOUS VEIN GRAFT (SVG ) TO FIRST OBTUSE MARGINAL (OM) WAS 70% OSTIAL STENOSIS AND 80% MID STENOSIS. TARGET LESION #3 WAS A DE-NOVO LESION LOCATED IN MID SVG TO FIRST OM WITH 80% STENOSIS AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 3.50 MM X 20 MM ION¿ STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION #4 WAS A WAS A DE-NOVO LESION LOCATED IN PROXIMAL SVG TO FIRST OM WITH 70% STENOSIS AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 3.50 MM X 20 MM ION¿ STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, A 2.5 MM X 8 MM PROMUS ELEMENT PLUS STENT WAS IMPLANTED AT THE SAPHENOUS VEIN GRAFT (SVG) TO FIRST OM. IN (B)(6) 2013, THE SUBJECT HAD CARDIAC ARREST. THE PATIENT'S CARDIAC ENZYMES WERE FOUND TO BE ELEVATED AND MI OCCURRED. ON THE SAME DAY, ELECTROCARDIOGRAM (ECG) WAS PERFORMED AND IT WAS OBSERVED THAT THE PATIENT EXPERIENCED ISCHEMIC SYMPTOMS. MICROSCOPIC EXAMINATION OF LEFT TONSIL REVEALED ¿DIFFUSE LARGE B-CELL LYMPHOMA¿. ONE DAY FROM ADMISSION, THE PATIENT HAD FURTHER BLEEDING FROM HIS TONSILLAR SITE, WAS HYPOTENSIVE. THE PATIENT STARTED HAVING WORSENING OF SYMPTOMS, HAD AN EPISODE OF ACUTE RESPIRATORY FAILURE AND DIED. PRIMARY CAUSE OF DEATH WAS MYOCARDIAL INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349245 ION? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902420350 14384132

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death