BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION¿

    MDR report key: 2840288 · Received November 20, 2012

    Report

    Report Number
    2134265-2012-07093
    Event Type
    Death
    Date Received
    November 20, 2012
    Date of Event
    July 8, 2012
    Report Date
    October 23, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME CASE AS MDR ID#: 2134265-2012-07092. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT HAD CARDIAC ARREST AND EXPIRED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO DYSPNEA ON EXERTION AND MYOCARDIAL PERFORMANCE INDEX (MPI) REVEALED INFERIOR ISCHEMIA, AND THEREFORE THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 1ST TARGET LESION WAS A BIFURCATED LESION LOCATED IN THE DISTAL LEFT CIRCUMFLEX ARTERY (DIST LCX) WITH 95% STENOSIS AND WAS 14MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 2.50X16MM ION COA STENT, WITH 0% RESIDUAL STENOSIS. THE 2ND TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MID LAD) WITH 70% STENOSIS AND WAS 18MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. FRACTIONAL FLOW RESERVE (FFR) MEASUREMENT WAS PERFORMED WHICH REVEALED FFR OF 0.68. THE LESION WAS TREATED WITH DIRECT PLACEMENT OF A 2.75X20MM ION COA STENT, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. REPEAT FFR REVEALED IMPROVED FFR OF 0.82. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2012, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH NAUSEA AND SORE THROAT WITH A FEELING LIKE HIS THROAT WAS CLOSING UP ON HIM. THE PATIENT WAS GIVEN STEROIDS AND WAS SENT HOME. THE PATIENT CAME BACK WITH COMPLAINTS OF COFFEE GROUNDS EMESIS AND BRIGHT RED BLOOD PER RECTUM AND WAS ALSO NOTED TO HAVE ELEVATED CREATININE AT 2.2. THE NEXT DAY, THE PATIENT PRESENTED WITH GASTROINTESTINAL (GI) BLEEDING AND ACUTE ONSET OF RENAL FAILURE, ALSO WITH A HISTORY OF CEREBROVASCULAR ACCIDENT WITH RIGHT SIDED WEAKNESS. THE ACUTE ONSET OF STROKE COULD NOT BE TREATED WITH TPA AS THE 3-HOUR WINDOW PERIOD WAS CROSSED. HE ALSO HAD SLURRED SPEECH AND DYSPHAGIA SYMPTOMS WHICH STARTED THE PREVIOUS NIGHT. HIS HYPERTENSION AND DIABETES WERE UNCONTROLLED WITH CHRONIC DIABETIC ULCER OF THE RIGHT SOLE PROXIMAL TO THE RIGHT HALLUX. HEAD CT WITHOUT CONTRAST WAS PERFORMED WHICH REVEALED NO ACUTE INTRACRANIAL PROCESS IDENTIFIED. THE PATIENT WAS PUT ON PROTON PUMP INHIBITOR FOR UPPER GI BLEED AND IV FLUIDS. THE RENAL ULTRASOUND WAS PERFORMED BECAUSE OF RENAL FAILURE. APPROXIMATELY 3.5 HOURS AFTER ADMISSION, THE PATIENT CODED. HE HAD ASYSTOLE AND VOMITED DARK BLACK BLOOD, HE WAS PLACED ON A VENTILATOR AND WAS TRANSFERRED TO THE SURGICAL INTENSIVE CARE UNIT (SICU). HE WAS GIVEN INSULIN, BICARBONATE, MAGNESIUM, AMIODARONE, IV FLUIDS AND WAS SHOCKED MULTIPLE TIMES. AFTER LONG TIME OF CODING, THE PATIENT LOST HIS PULSE AGAIN AND WENT INTO ASYSTOLE WHILE ON VENTILATOR AND EPINEPHRINE DRIP. AT 10:15PM THE PATIENT DIED. PER DEATH CERTIFICATE THE PRIMARY CAUSE OF DEATH IS CARDIAC ARREST AND THE UNDERLYING CAUSES ARE GI BLEEDING AND ACUTE RENAL FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902420270 14895240

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death