BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2912173 · Received January 11, 2013

    Report

    Report Number
    2024168-2013-00268
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 6, 2012
    Report Date
    December 17, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ISCHEMIA AND RESTENOSIS, AS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) ARE KNOWN ADVERSE PATIENT EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011, DUE TO POSITIVE STRESS TEST, THE SUBJECT UNDERWENT THE INDEX PROCEDURE WITH THE DEPLOYMENT OF ONE DRUG ELUTING STENT (DES) TO THE MID RIGHT CORONARY ARTERY (RCA) AND TWO DES TO THE PROXIMAL RCA. POST PROCEDURE RESIDUAL STENOSIS WAS 10 % WITH TIMI 3 FLOW TO BOTH OF THE LESIONS. ON (B)(6) 2011, THE SUBJECT WAS DISCHARGED FROM THE INDEX HOSPITALIZATION. ON (B)(6) 2011, THE SUBJECT UNDERWENT A STAGED PROCEDURE WITH SUCCESSFUL DEPLOYMENT OF FOUR DES TO THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY AND TWO DRUG ELUTING STENTS TO THE FIRST DIAGONAL (D1) ARTERY. POST PROCEDURE RESIDUAL STENOSIS WAS 10%. ON (B)(6) 2012, 634 DAYS POST PROCEDURE, THE SUBJECT EXPERIENCED THE EVENT OF IN-STENT RESTENOSIS. THE EVENT WAS REPORTED WITH THE SERIOUS CRITERIA OF INITIAL OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THE PATIENT WAS SEEN FOR CARDIAC CLEARANCE FOLLOWING EVIDENCE OF REVERSIBLE ISCHEMIA. ON (B)(6) 2012, THE PATIENTS CARDIAC ENZYMES REVEALED THAT TROPONIN WAS LESS THAN 0.01NG/ML (REFERENCE RANGE NOT PROVIDED) AND CKMB WAS 6.20NG/ML (REFERENCE RANGE 0.60 - 6.30NG/ML). THE PATIENTS CARDIAC CATHETERIZATION REVEALED 50% TO 70% IN-STENT STENOSIS OF THE OSTIUM OF THE DIAGONAL AND IN-STENT STENOSIS OF THE RCA. THE PATIENT HAD A BARE METAL STENT DEPLOYED TO THE RCA REDUCING THE FINAL RESIDUAL STENOSIS TO LESS THAN 10 %. THE OUTCOME OF THE EVENT IS RECOVERED OR RESOLVED. IT WAS NOTED THAT THE INVESTIGATOR CONSIDERED THE EVENT OF IN-STENT RESTENOSIS OF A STUDY STENT, MODERATE IN INTENSITY, AND NOT RELATED TO THE STUDY DRUG, PROBABLY RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE STUDY PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16495 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0072941

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R