BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1610295 · Received February 12, 2010

    Report

    Report Number
    2024168-2010-00246
    Event Type
    Injury
    Date Received
    February 12, 2010
    Date of Event
    October 17, 2008
    Report Date
    January 19, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE OTHER TWO PROMUS STENTS (PART 1009530-12B, LOT 8041661) AND (PART 1009529-15B, LOT 8030741), HAVE BEEN FILED UNDER THE SAME MFR#.

    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 VIA A TRIAL, THAT THE INITIAL PROCEDURE WAS PERFORMED ON (B) (6) 2008. THE TARGET LESION WAS LOCATED IN THE SAPHENOUS VEIN GRAFT (SVG) TO RIGHT-POSTERIOR DESCENDING ARTERY (PDA) WITH 75% STENOSIS AND WAS 45 MM LONG WITH A 3.5 MM REFERENCE VESSEL DIAMETER. THE TARGET LESION WAS TREATED WITH PLACEMENT OF 3.5 X 23 MM, 3.5 X 12 MM, AND 3.0 X 15 PROMUS STENTS WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON (B) (6) 2008, ON ASPIRIN AND CLOPIDOGREL. ON (B) (6) 2008, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION OF THE SVG TO R-PDA. IT WAS NOTED THAT A PREVIOUSLY PLACED STENT HAD 0% DIAMETER STENOSIS WITH FOCAL IN-STENT RESTENOSIS. THE TARGET LESION WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A XIENCE STENT. POST-TREATMENT STENOSIS WAS 0%. THE EVENT WAS CONSIDERED RESOLVED. THERE WAS NO ADDITIONAL SEQUELA REPORTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION 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 8040761

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R STENT: 3.5 X 12 MM PROMUS (PART 1009530-12B,| LOT 8041661),| 3.0 X 15 MM (PART 1009529-15B, LOT 8030741)