BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON

    MDR report key: 8784850 · Received July 12, 2019

    Report

    Report Number
    3009784280-2019-00505
    Event Type
    Injury
    Date Received
    July 12, 2019
    Date of Event
    December 7, 2018
    Report Date
    June 21, 2019
    Manufacturer
    SPECTRANETICS
    Product Code
    ONU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REQUIRED AMPUTATION ON THE TREATED LIMB. THIS IS BEING REPORTED AS A FOLLOW-UP TO THE CLINICAL REGISTRY. PATIENT INFORMATION REGARDING RELEVANT TESTS OR 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, THUS NO PRODUCT EVALUATION WAS REQUIRED. PER THE IFU, AMPUTATION IS LISTED AS 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) 2018, TWO STELLAREX CATHETERS WERE USED TO TREATED THE TARGET LESION OF THE LEFT MID SFA. APPROXIMATELY 8 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED ATHEROSCLEROSIS OF EXTREMITIES WITH GANGRENE. A MINOR AMPUTATION OF THE LEFT FRONT FOOT WAS PERFORMED ON (B)(6) 2018. THE PHYSICIAN INDICATED THIS IS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578355 STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON DCB PTA CATHETER ONU SPECTRANETICS A35SX060040080 FBZ17D10A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R