BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2800223 · Received October 22, 2012

    Report

    Report Number
    2134265-2012-06348
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    August 1, 2011
    Report Date
    September 24, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PATIENT AS MDR ID#: 2134265-2012-06359, 2134265-2012-06360. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT HAD CHEST PAIN AND A MYOCARDIAL INFARCTION (MI). IN (B)(6) 2011, THE PATIENT PRESENTED DUE TO STABLE ANGINA (CCS CLASSIFICATION 2) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 1ST TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (MID RCA) WITH 80% STENOSIS AND WAS 13MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 3.00X12MM PROMUS ELEMENT STENT, WITH 0% RESIDUAL STENOSIS. THE 2ND TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (DIST RCA) WITH 60% STENOSIS AND WAS 13MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 2.50X12MM PROMUS ELEMENT STENT, WITH 20% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THE 3RD TARGET LESION WAS LOCATED IN THE ACUTE MARGINAL BRANCH (AC MARG) WITH 80% STENOSIS AND WAS 14MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 2.25X16MM PROMUS ELEMENT STENT, WITH 80% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THIS STENT WAS NOT WELL DEPLOYED BECAUSE OF EXCESSIVE CALCIFICATION. DURING THE INDEX PROCEDURE, A RUNWAY FR-4 GUIDE CATHETER, AN IQ 185CM J-TIP GUIDEWIRE AND A 2.0X15MM APEX CATHETER WERE UNABLE TO CROSS THE DISTAL LESION. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2011, ELEVATED TROPONIN VALUES WERE OBSERVED AND A NON Q-WAVE MYOCARDIAL INFARCTION WAS REPORTED. THE PATIENT EXPERIENCED ISCHEMIC SYMPTOMS WITH RECURRENT CHEST PAIN LASTING FOR MORE THAN 20 MINUTES. THE EVENT WAS CONSIDERED AS RESOLVED WITH RESIDUAL EFFECTS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316220 13106738

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other