BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1927045 · Received December 14, 2010

    Report

    Report Number
    2024168-2010-02760
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    May 14, 2010
    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
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). STENOSIS IS LISTED IN THE PROMUS INSTRUCTION FOR USE AS A NO-FAULT POST-PROCEDURE EFFECT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF MI IS LISTED IN THE PRODUCT INSTRUCTION FOR USE AS A NO-FAULT POST-PROCEDURE EFFECT. 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 THAT THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) (CASS SITE 1) WITH 80% STENOSIS, A LENGTH OF 12 MM, AND REFERENCE VESSEL DIAMETER OF 3.5 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.5 X 12 MM STUDY STENT WITH 0% RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED ON (B)(6) 2009, ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2010, THE SITE REPORTED THAT AN EVENT OF MYOCARDIAL INFARCTION WITH AN ONSET OF (B)(6) 2010. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2010, 372 DAYS POST INDEX PROCEDURE, AND TREATED WITH TARGET VESSEL REVASCULARIZATION. THE EVENT RESOLVED WITHOUT RESIDUAL EFFECTS ON (B)(6) 2010. 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.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH REPORT FILED, NEW INFORMATION RECEIVED STATES THAT IN-STENT RESTENOSIS WAS OBSERVED IN THE PREVIOUSLY DEPLOYED 3.5X12 MM PROMUS STENT WHICH REQUIRED TREATMENT WITH A 3.0X15 MM PROMUS STENT. 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 8101061

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R| S