BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1631455 · Received March 12, 2010

    Report

    Report Number
    2024168-2010-00488
    Event Type
    Injury
    Date Received
    March 12, 2010
    Date of Event
    February 10, 2010
    Report Date
    February 16, 2010
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). MFR REFERENCE# 2024168-2010-00474 FOR 10 PARTS INCLUDED THIS PART# 1009540-28B/LOT# 9081361. EVAL SUMMARY: IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. ALLERGIC REACTION IS A KNOWN ADVERSE EVENT AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE (IFU) AND NO FAULT RISK ASSESSMENT MATRIX. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT 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. ALTHOUGH A CONCLUSIVE CAUSE CANNOT BE DETERMINED FOR THE REPORTED PT EFFECT, NO CORRECTIVE ACTION WILL BE INITIATED AS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A 100% VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL (Q.C.) AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: ALLERGIC REACTION. ONSET OF ADVERSE EVENT: POST STENT IMPLANTATION. IT WAS REPORTED THAT THE PT DEVELOPED A RASH TO HIS BUTTOCKS WITH REDNESS AND ITCHING AFTER THE TEN PROMUS STENTS HAD BEEN IMPLANTED. THE SYMPTOMS WERE NOTED ON (B) (6) 2010. NO ADD'L EVENT OR PT INFO IS AVAILABLE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B) (4) 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 9081361

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention PROMUS RX DEVICES: 3.0 X 28 MM| 2.5 X 28 MM| 3.5 X 18 MM| 2.75 X 28 MM| 3.5 X 28 MM| 3.0 X 28 MM| 3.5 X 23 MM| 3.5 X 08 MM| 3.5 X 12 MM