BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1241528 · Received November 21, 2008

    Report

    Report Number
    2024168-2008-01205
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 23, 2008
    Report Date
    October 24, 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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. PERFORATION, AS LISTED IN THE PROMUS IFU, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. IN THIS CASE, IT IS POSSIBLE THAT THE OTHER CO'S BALLOON RUPTURE, STENT DEPLOYMENT AT 22 ATM AND MULTIPLE POST DILATATIONS PERFORMED MAY HAVE CONTRIBUTED TO THE REPORTED PERFORATION. THE PROMUS IFU STATES, "RATED BURST PRESSURE (RBP): 16 ATM FOR ALL SIZES ... DO NOT EXCEED RBP AS INDICATED ON THE PRODUCT LABEL." HOWEVER, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED PT EFFECTS, AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED.

    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 THAT THE PT WAS PRESENTED ON A BALLOON PUMP; THEREFORE, IT WAS DECIDED TO NOT OPERATE ON THE PT. PREDILATATION WAS PERFORMED WITH A POWERSAIL. THE 2.75 X 23 MM PROMUS STENT WAS DEPLOYED AT 20 ATM. POST-DILATATION WAS PERFORMED WITH THE PROMUS BALLOON AT 22 ATM AND A PERFORATION OCCURRED. AN ATTEMPT WAS MADE TO TREAT THE PERFORATION WITH A JOMED GRAFTMASTER STENT, BUT WAS NOT SUCCESSFUL. THE PHYSICIAN WAS HOPING THE PERFORATION WOULD SEAL ON ITS OWN. IT WAS LATER REPORTED THAT THE PT IS NO LONGER ON THE BALLOON PUMP. NO ADDITIONAL 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention POWERSAIL| DILATATION CATHETER: MAVERICK