BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION?

    MDR report key: 3121909 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03506
    Event Type
    Death
    Date Received
    May 21, 2013
    Date of Event
    October 30, 2012
    Report Date
    April 22, 2013
    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

    (B)(6). DEVICE IS A COMBINATION PRODUCT. THE DEVICE HAS NOT BEEN RETURNED 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

    (B)(4) CLINICAL STUDY. SAME CASE AS MDR ID: 2134265-2013-03508, 2134265-2013-03507. IT WAS REPORTED THAT POST PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, CONGESTIVE HEART FAILURE AND DEATH OCCURRED. IN (B)(6) 2012, THE SUBJECT PRESENTED WITH SUPRAVENTRICULAR TACHYCARDIA AND CORONARY ISCHEMIA. THE INDEX PROCEDURE WAS PERFORMED. TARGET LESION #1 WAS A LESION LOCATED IN THE DISTAL OF THE RIGHT CORONARY ARTERY WITH 80% STENOSIS AND WAS 16 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.7 MM. TARGET LESION #1 WAS TREATED WITH PRE DILATATION AND PLACEMENT OF A 2.25 MM X 16 MM ION STENT DELIVERY SYSTEM. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0 %. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2012, THE SUBJECT RETURNED TO CATHERIZATION LABORATORY FOR THE STAGED PROCEDURE TO THE LEFT CIRCUMFLEX ARTERY. TARGET LESION # 2 WAS A LESION LOCATED IN THE DISTAL OF THE LEFT CIRCUMFLEX ARTERY WITH 75% STENOSIS AND WAS 32 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.6 MM. TARGET LESION # 2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 MM X 32 MM ION STENT DELIVERY SYSTEM. TARGET LESION # 3 WAS A LESION LOCATED IN THE PROXIMAL OF THE LEFT CIRCUMFLEX ARTERY WITH 80% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.4 MM. TARGET LESION # 3 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 MM X 12 MM ION STENT DELIVERY SYSTEM. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE SUBJECT WAS ADMITTED DUE TO EXACERBATION OF CONGESTIVE HEART FAILURE AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) EXACERBATION. MEDICATIONS WERE GIVEN TO TREAT THIS EVENT. ON THE EIGHTH DAY, THE SUBJECT WAS DISCHARGED. THE SUBJECT EXPIRED THREE WEEKS AFTER DISCHARGE. THE CAUSE OF DEATH WAS COPD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224130 ION? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902316220 14026668

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death