BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1211526 · Received October 22, 2008

    Report

    Report Number
    2024168-2008-01003
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE THREE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS ARE BEING FILED UNDER THE SAME MFR NUMBER. RESULTS AND CONCLUSION SUMMATION- ANGINA AND THROMBOSIS, AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING AND ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. IN THIS CASE, IT IS LIKELY THAT THE ANGINA AND ADDITIONAL TREATMENT ARE SECONDARY EFFECTS OF THE THROMBOSIS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE; 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: THROMBOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT IN 2008, AFTER PREDILATATION, TWO PROMUS STENTS (2.5X28MM, 2.5X15MM) WERE PLACED IN THE RIGHT CORONARY ARTERY (RCA) AND INFLATED TO 16 ATM FOR 30 SECONDS EACH. EVERYTHING LOOKED GOOD. THE PT WAS BROUGHT BACK TO THE LAB ON THE NEXT DAY, AND ONE PROMUS STENT (2.5X23MM) WAS PLACED IN THE 2ND OBTUSE MARGINAL (OM) AND THE 3RD OM WAS IMPLANTED WITH TWO PROMUS STENTS (2.5X23MM, 2.5X15MM). PREDILATATION WAS NOT PERFORMED. EACH STENT WAS IMPLANTED AT 16 ATM FOR 30 SECONDS. AN ANGIOGRAM WAS DONE AND THEY DECIDED TO PLACE A PROMUS STENT (2.5X18MM) BETWEEN THE TWO PREVIOUSLY PLACED STENTS IN THE RCA. ON THE FOLLOWING DAY, THE PT EXPERIENCED CHEST PAIN AND THE ANGIOGRAM REVEALED STENT THROMBOSIS IN THE RCA AND THE 2ND OM. AN ASPIRATION CATHETER WAS USED, AS WELL AS A BALLOON, TO RESTORE FLOW. THE PT IS DOING FINE AND WITHOUT CHEST PAIN. NO ADDITIONAL EVENT OR PT INFO 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 U.S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8072461

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention STENTS: PROMUS EVEROLIMUS ELUTING CORONARY STENT| 2.5X20 OTW MAVERICKS| LOT# 8041641| SYSTEM LOT# 8071561| DIL CATH: 1.5X15 OTW| LOT#8041741