BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1231850 · Received November 12, 2008

    Report

    Report Number
    2024168-2008-01131
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    May 28, 2008
    Report Date
    October 13, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. STENOSIS, AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. STENOSIS IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE AND IN THIS CASE, THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION AT THE TIME OF THE IMPLANT.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: STENOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT VIA A TRIAL THE INITIAL PROCEDURE PERFORMED IN 2008, INVOLVED THREE TARGET LESIONS. THE FIRST LESION WAS DIRECT STENTED WITH A 2.5 X 18 MM PROMUS. PRE-DILATATION WAS PERFORMED ON THE SECOND LESION, LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) AND A 2.5 X 18 MM PROMUS STENT WAS IMPLANTED, RESULTING IN 0% RESIDUAL STENOSIS. THE THIRD LESION IN THE DISTAL LAD, WAS TREATED WITH DIRECT STENTING USING A 2.5 X 28 MM PROMUS. A GRADE A DISSECTION PROXIMAL TO THE STENT OCCURRED DURING PLACEMENT AND A 2.5 X 8 MM PROMUS WAS IMPLANTED TO TREAT THE DISSECTION RESULTING IN 0% RESIDUAL STENOSIS. THE PT WAS DISCHARGED TWO DAYS POST INITIAL PROCEDURE ON ASPIRIN AND PLAVIX. THE PT RETURNED THE FOLLOWING MONTH, DUE TO 95% STENOSIS OF THE PROXIMAL LAD AND WAS TREATED WITH A XIENCE STENT RESULTING IN 0% RESIDUAL STENOSIS. NO ADD'L EVENT OR PT INFO IS AVAILABLE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORP 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 NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8012141

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention