BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2990085 · Received March 5, 2013

    Report

    Report Number
    2134265-2013-01197
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    December 3, 2010
    Report Date
    February 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). (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. THE MANUFACTURING BATCH RECORD REVIEW CONFORMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS THE COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN & MANUFACTURE SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED. (B)(4).

    Description of Event or Problem · 1

    (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE STENT DID NOT ADEQUATELY COVER THE LESION. IN (B)(6) 2010, THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 1ST DE NOVO LONG TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (MID RCA) EXTENDING TO DISTAL RCA WITH 99% STENOSIS AND WAS 20MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF TWO OVERLAPPING PROMUS ELEMENT STENTS OF SIZE 3.50X32MM AND 3.50X28MM, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. IN (B)(6) 2010, THE PATIENT RETURNED FOR A STAGED PROCEDURE. THE 2ND DE NOVO LONG TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MID LAD) EXTENDING TO DISTAL LAD WITH 95% STENOSIS AND WAS 15MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 2.50X24MM PROMUS ELEMENT STENT. POST STENT DEPLOYMENT, THE LESION WAS "NOT PERFECTLY COVERED DUE TO STENT DEFICIENCY", WHICH WAS TREATED WITH PLACEMENT OF A 2.50X12MM PROMUS ELEMENT STENT IN OVERLAPPING MANNER, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THE 3RD DE NOVO TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MID LAD) WITH 90% STENOSIS AND WAS 5MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.7MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 3.00X8MM PROMUS ELEMENT STENT IN OVERLAPPING MANNER, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94304 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911324250 13840080

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention