BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION¿

    MDR report key: 2840923 · Received November 20, 2012

    Report

    Report Number
    2134265-2012-07207
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 26, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME PATIENT AS MFR# 2134265-2012-04470; 2134265-2012-04471, 2134265-2012-04472, 2134265-2012-04524; 2134265-2012-04678; 2134265-2012-04679; 2134265-2012-04680; 2134265-2012-04681; 2134265-2012-04707; 2134265-2012-04799; 2134265-2012-04974; 2134265-2012-05451. SAME CASE AS 2134265-2012-07205; 2134265-2012-07206; 2134265-2012-07208; 2134265-2012-07212, 2134265-2012-07214, 2134265-2012-07215 AND 2134265-2012-07213 IT WAS REPORTED THAT DURING A CORONARY ARTERY TREATMENT PROCEDURE, THE PATIENT EXPERIENCED ANGINA AND RESTENOSIS. IN (B)(6) 2012, THREE PROMUS ELEMENT PLUS STENTS, SIZES 3.0 X 12 MM, 3.0 X 24 MM AND 3.0 X 24 MM, WERE IMPLANTED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). IN (B)(6) 2012, LESION 1 WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (DIST LAD) ARTERY WITH 90% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT STENT PLACEMENT USING A 2.25 MM X 24 MM ION STENT OVERLAPPING PROXIMALLY WITH THE STUDY STENT DEPLOYED IN THE MID LEFT ANTERIOR DESCENDING (MID LAD) ARTERY. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. LESION 2 WAS LOCATED IN THE MID LAD WITH 90% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3 MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT STENT PLACEMENT USING A 2.75 MM X 28 MM ION STENT OVERLAPPING PROXIMALLY WITH THE STUDY STENT DEPLOYED IN PROXIMAL LAD AND DISTALLY WITH THE STUDY STENT DEPLOYED IN THE DIST LAD. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. LESION 3 WAS LOCATED IN THE PROXIMAL LAD WITH 90% STENOSIS AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4 MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT STENT PLACEMENT USING A 3.50 MM X 28 MM ION STENT OVERLAPPING DISTALLY WITH THE STUDY STENT DEPLOYED IN THE MID LAD. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE PATIENT PRESENTED DUE CHEST PAIN AND WAS HOSPITALIZED ON THE SAME DAY. THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. THERE WAS 90% DIFFUSE RESTENOSIS OF THE PREVIOUSLY PLACED STUDY AND NON-STUDY STENTS (3 PROMUS ELEMENT STENTS) LOCATED IN THE MID LAD EXTENDING TOWARDS THE DISTAL LAD. A 3.5 MM RUNWAY GUIDE CATHETER WAS PLACED ACROSS THE IN-STENT RESTENOSIS (ISR). THE ISR WAS TREATED USING A 3.5 MM X 12 MM APEX BALLOON WITH 0% RESIDUAL STENOSIS. DURING THE PROCEDURE THE PATIENT EXPERIENCED CHEST PAIN/ LEFT ARM PAIN, POST INSERTION OF THE 3.5 MM RUNWAY GUIDE CATHETER AND INFLATION OF THE 3 MM X 12 MM APEX BALLOON. THIS WAS TREATED WITH FENTANYL IV. AFTER THE PROCEDURE THE PATIENT DEVELOPED NO REFLOW WHICH WAS TREATED WITH ADENOSINE AND NITROGLYCERINE INJECTIONS, WHICH RESOLVED THE NO REFLOW. FOUR DAYS LATER, THE PATIENT PRESENTED DUE TO SUDDEN ONSET OF LEFT CHEST PAIN RADIATING TO HIS LEFT JAW AND ARM ASSOCIATED WITH DIAPHORESIS NAUSEA AND WAS HOSPITALIZED ON THE SAME DAY. MEDICATION WAS GIVEN TO TREAT THE EVENT. THE PATIENT WAS DISCHARGED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO ANGINA AND WAS HOSPITALIZED THE SAME DAY. MEDICATION WAS GIVEN TO TREAT THE EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT IN (B)(6) 2012, THE PATIENT PRESENTED WITH RECURRENT CHEST PAIN WITHOUT RESOLUTION AFTER NITROGLYCERINE. THE CARDIAC ENZYMES WERE FOUND TO BE ELEVATED, THE SITE REPORTED AN EVENT OF MYOCARDIAL INFARCTION (MI). (PEAK CK=529 IU/L; ULN=174 IU/L; PEAK CK-MB IS 25.6; ULN=< 5.9 NG/ML; PEAK TROPONIN =0.42 NG/M; ULN=<0.03 NG/ML). ECG WAS PERFORMED AND THE TYPE OF MI WAS CONFIRMED AS A NON Q-WAVE MI. IT WAS OBSERVED THAT THE PATIENT EXPERIENCED ISCHEMIC SYMPTOMS. THE 100% STENOSIS DISTAL TO THE PREVIOUSLY PLACED STUDY STENT LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WAS ATTEMPTED TO BE TREATED WITH BALLOON ANGIOPLASTY USING AN APEX BALLOON. HOWEVER, RUNWAY GUIDE CATHETER SCIMED 6FR FL4, SCIMED 6FR AR1 AND SCIMED 6FR PIG CATHETERS WERE ALSO INSERTED WHICH RESTORED MINIMAL FLOW OR NO FLOW SO AFTER A FEW ANGIOPLASTIES WITH BALLOON IT WAS DECIDED TO STOP THE PROCEDURE AND ALL CATHETERS AND WIRES WERE WITHDRAWN. THE SITE HAS CONFIRMED THAT NONE OF THE BSC PRODUCTS WERE RESPONSIBLE FOR THE "NO FLOW." MEDICATION WAS GIVEN TO TREAT THE EVENT AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902428350 14702031

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention 3.0 X 12 MM PROMUS ELEMENT PLUS STENT| 3.0 X 24 MM PROMUS ELEMENT PLUS STENT| 2.75 X 28 MM ION STENT| 2.25 X 24 MM ION STENT