BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1274880 · Received December 23, 2008

    Report

    Report Number
    2024168-2008-01520
    Event Type
    Injury
    Date Received
    December 23, 2008
    Date of Event
    November 17, 2008
    Report Date
    December 1, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: PERFORATION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL, THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION, IN-STENT RESTENOSIS OF THE MILDLY CALCIFIED, MILDLY TORTUOUS, MID RCA. TREATMENT CONSISTED OF PREDILATION AND PLACEMENT OF TWO OVERLAPPING 2.5 X 28 MM PROMUS STENTS RESULTING IN 0 RESIDUAL STENOSIS. A VESSEL PERFORATION WAS ASSOCIATED WITH ONE OF THE PROMUS STENTS (LOT: 8060441). THE PERFORATION WAS TREATED WITH A 30 MINUTE BALLOON INFLATION AND THE IMPLANTATION OF A 3.0 X 16 GRAFTMASTER STENT. TIMI FLOW POST PROCEDURE AT BOTH STENTS WAS 3. THE PATIENT WAS DISCHARGED IN 2008, ON ASA AND PLAVIX. THE PATIENT IS IN GOOD CONDITION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. 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 NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8060441

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention STENT: 2.5 28 MM PROMUS