BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINTER LEGEND BALLOON DILATATION CATHETER

    MDR report key: 1920039 · Received December 3, 2010

    Report

    Report Number
    2953200-2010-02386
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    June 8, 2010
    Report Date
    November 5, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS/CONCLUSIONS: (DISTAL RCA HAD AN 80% ECCENTRIC STENOSIS, PROXIMAL RCA HAD A 50% TUBULAR STENOSIS), (DISSECTION).

    Description of Event or Problem · 1

    THE PHYSICIAN SUCCESSFULLY IMPLANTED A 3.0 MM DIAMETER X 15 MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO THE PROXIMAL RCA (REF MFR # 2953200201002385). THE PROXIMAL RCA HAD A 50% TUBULAR STENOSIS AND THE DISTAL RCA HAD AN 80% ECCENTRIC STENOSIS. A 2.5 MM X 12 MM SPRINTER LEGEND BALLOON WAS USED DURING THE PROCEDURE TO TREAT THE DISTAL RCA. A 3.0 MM X 15 MM SPRINTER LEGEND BALLOON WAS ALSO USED TO TREAT THE MID RCA (REF MFR # 2953200201002387). IT IS REPORTED THAT A DISSECTION OCCURRED DURING THE INDEX PROCEDURE WHICH REQUIRED THE PLACEMENT OF A PROXIMAL STENT. THE POST-PROCEDURE WHICH REQUIRED THE PLACEMENT OF A PROXIMAL STENT. THE POST-PROCEDURE COURSE WAS UNCOMPLICATED AND THE PT WAS DISCHARGED. NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINTER LEGEND BALLOON DILATATION CATHETER LOX MEDTRONIC CARDIOVASCULAR GALWAY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention CLOPIDOGREL| ASPIRIN