BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON

    MDR report key: 8663510 · Received June 3, 2019

    Report

    Report Number
    3009784280-2019-00338
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    January 31, 2019
    Report Date
    May 13, 2019
    Manufacturer
    SPECTRANETICS
    Product Code
    ONU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REQUIRED REVASCULARIZATION OF THE TARGET LESION. THIS IS BEING REPORTED AS A FOLLOW UP TO THE CLINICAL REGISTRY. PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA IS UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. REPORT SOURCE: FOREIGN- (B)(6) , STUDY NAME: (B)(6): PATIENT ID # (B)(6). PMA NUMBER IS NOT APPLICABLE. THE DEVICE IS A COMMERCIAL PRODUCT WITH A CE MARK THAT WAS USED AS PART OF A CLINICAL REGISTRY. DURING THE INDEX PROCEDURE, THE PRODUCT WORKED AS INTENDED. THE DEVICE WAS DISCARDED, THUS NO PRODUCT EVALUATION WAS PERFORMED. PER THE IFU, OCCLUSION IS LISTED AS A POTENTIAL COMPLICATIONS/ADVERSE EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE ON (B)(6) 2017, TWO STELLAREX CATHETERS WERE USED TO TREAT THE TARGET LESION OF THE LEFT POPLITEAL P1, P2. APPROXIMATELY 15 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED AN OCCLUSION. A SUCCESSFUL REVASCULARIZATION OF THE TARGET LESION WAS PERFORMED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457636 STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON DCB PTA CATHETER ONU SPECTRANETICS A35SX050120135 FFX17D10A

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R