BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION¿

    MDR report key: 2752837 · Received September 20, 2012

    Report

    Report Number
    2134265-2012-05824
    Event Type
    Injury
    Date Received
    September 20, 2012
    Date of Event
    August 19, 2012
    Report Date
    August 24, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED LESION LOCATION FROM MID RCA TO 1ST DIAGONAL. CORRECTED STABLE ANGINA CLASSIFICATION IN PATIENT HISTORY. EVENT DESCRIPTION AND OTHER RELEVANT HISTORY UPDATED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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).

    Description of Event or Problem · 1

    (B)(6) CLINICAL STUDY. SAME CASE AS 2134265-2012-05823; 2134265-2012-05825. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. LESION 1 WAS LOCATED IN A SAPHENOUS VEIN GRAFT (SVG) TO THE RAMUS WITH 95% STENOSIS AND WAS 6 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 12 MM ION STENT WITH 0% RESIDUAL STENOSIS. LESION 2 WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 90% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 16 MM ION STENT WITH 0% RESIDUAL STENOSIS. LESION 3 WAS LOCATED IN THE DISTAL LAD WITH 90% STENOSIS AND WAS 8MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 2.25 MM X 12 MM ION STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND TICLOPIDINE. IN (B)(6) 2012, THE PATIENT HAD ELEVATED CARDIAC ENZYMES AND AN EVENT OF MYOCARDIAL INFARCTION (MI) WAS REPORTED (PEAK VALUES = CK-MB-1521 OIU/L; ULN= 135 IU/L; CK-MB=100 NG/ML; ULN= 5 NG/ML; TROPONIN I= 193 NG/L; ULN= 0.03 NG/L). ECG WAS PERFORMED (TYPE OF MI= ANTERIOR (SEPTAL) WITH ST SEGMENT ELEVATION) AND NO ISCHEMIC SYMPTOMS WERE NOTED. THE PATIENT UNDERWENT REVASCULARIZATION OF THE TARGET VESSEL THE DETAILS OF WHICH ARE UNKNOWN. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT TARGET LESION 1 AT THE TIME OF THE INDEX PROCEDURE IN (B)(6) 2012, WAS A RESTENOTIC LESION (WITH NO STENTS) LOCATED IN SVG TO 1ST DIAGONAL NOT SVG TO THE RAMUS AS PREVIOUSLY REPORTED. THE PATIENT WAS DISCHARGED ON TICAGRELOR (PER SOURCE). IN (B)(6) 2012 AT THE TIME OF THE EVENT, THE SITE HAS CONFIRMED THERE WAS NO STENT THROMBOLYSIS. THE PATIENT WAS DISCHARGED ON THE SAME DAY ON ASPIRIN AND TICAGRELOR .

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS IN DIAGONAL GRAFT. AT THE TIME OF THE EVENT, THE PATIENT PRESENTED WITH ACUTE CHEST PAIN. THE PATIENT RECEIVED THROMBOLYSIS WITH TNK. ST CHANGES WERE RESOLVED WITH RESOLUTION OF CHEST PAIN. 2-DIMENSIONAL ECHOCARDIOGRAPHY WAS PERFORMED WHICH DEMONSTRATED SEPTAL APICAL HYPOKINESIS CONSISTENT WITH APICAL ANEURYSM AND ISCHEMIC CARDIOMYOPATHY. THE 90% STENOSIS IN THE MID LAD WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 2.25 X 12 MM PROMUS STENT, WITH 0% RESIDUAL STENOSIS. THE 80% STENOSIS IN THE OSTIAL LMCA WAS ALSO TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 3.5 X 8 MM PROMUS STENT, WITH 0% RESIDUAL STENOSIS. ADDITIONALLY, THE 80% STENOSIS IN THE SVG TO THE 1ST DIAGONAL WAS TREATED WITH PLACEMENT OF A 2.5 X 28 MM PROMUS ELEMENT STENT, WITH 0% RESIDUAL STENOSIS. THE PATIENT ALSO RECEIVED 5 UNITS OF BLOOD. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS 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 H7493902416250 14333684

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention 2.50X12MM ION STENT| 2.25X12MM ION STENT