BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1925098 · Received December 14, 2010

    Report

    Report Number
    2024168-2010-02728
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    July 21, 2009
    Report Date
    November 19, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. OCCLUSION IS A KNOWN ADVERSE EVENT AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINICAL TRIAL THE TARGET LESION # 1 WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA), (B)(4) WITH 99% STENOSIS, A LENGTH OF 12 MM, AND A REFERENCE VESSEL DIAMETER OF 2.50 MM. PRE-DILATATION WAS PERFORMED PRIOR TO PLACEMENT OF A 2.50 X 18/20 MM STUDY STENT, AND POST-DILATATION LEFT A 0% RESIDUAL STENOSIS. TARGET LESION # 2 WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD), (B)(4), WITH 75% STENOSIS, A LENGTH OF 10 MM, AND A REFERENCE VESSEL DIAMETER OF 3.0 MM. PRE-DILATATION WAS PERFORMED PRIOR TO PLACEMENT OF A 3.0 X 18/20 MM STUDY STENT, AND POST-DILATATION WITH 0% RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED ON (B)(6) 2009 ON ASPIRIN AND CLOPIDOGREL. POST PROCEDURE THE PATIENT WAS REPORTED TO HAVE NO REFLOW IN THE DISTAL RCA. THERE WAS NO REPORTED TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    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 8093061

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Disability