BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2628015 · Received June 25, 2012

    Report

    Report Number
    2024168-2012-03997
    Event Type
    Injury
    Date Received
    June 25, 2012
    Date of Event
    September 2, 2009
    Report Date
    May 31, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE IF ANY CANNOT BE DETERMINED, STENOSIS/RESTENOSIS IS LISTED IN THE JAPAN PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT OF CORONARY STENTING PROCEDURES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US. THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT FILING ADDITIONAL INFORMATION RECEIVED: AFTER STENT DEPLOYMENT DURING THE INDEX PROCEDURE, IT WAS OBSERVED ON INTRAVASCULAR ULTRASOUND THAT PART OF THE STENT WAS NOT ADEQUATELY EXPANDED. POST DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON, TWICE. IT WAS CONFIRMED THAT THE STENT WAS FULLY EXPANDED; HOWEVER, ON ANGIOGRAPHY THERE APPEARED TO BE A STENOSIS IN THE PROXIMAL END OF THE STENT THAT REQUIRED ADDITIONAL DILATATION WITH THE SAME NON-ABBOTT BALLOON TWICE. THE STENOSIS HAD MILDLY IMPROVED AND THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT CIRCUMFLEX WITH A 90% STENOSIS. THE TARGET LESION WAS TREATED WITH PRE-DILATATION, AND PLACEMENT OF A 3.0 X 12 MM PROMUS STENT, AND POST-DILATATION WAS PERFORMED LEAVING 0% RESIDUAL STENOSIS; HOWEVER, THERE WAS A REPORT OF STENT DEFORMATION OF THE STENT. THE SUBJECT WAS DISCHARGED ON (B)(6) 2009 ON ASPIRIN AND CLOPIDOGREL. THE SITE REPORTED AN EVENT OF CORONARY STENOSIS WITH AN ONSET DATE OF (B)(6) 2011; HOWEVER, IT IS UNKNOWN IF ANY TREATMENT WAS PERFORMED. ON (B)(6) 2012, 995 DAYS POST INDEX PROCEDURE, HE SUBJECT WAS HOSPITALIZED AND UNDERWENT A TARGET VESSEL REVASCULARIZATION AND A NON-TARGET VESSEL REVASCULARIZATION. THE EVENT RESOLVED WITHOUT RESIDUAL EFFECTS ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8102061

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R