BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON

    MDR report key: 8805200 · Received July 18, 2019

    Report

    Report Number
    3009784280-2019-00530
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    January 9, 2019
    Report Date
    July 1, 2019
    Manufacturer
    SPECTRANETICS
    Product Code
    ONU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT: CORRECTED APPROXIMATE MONTHS FROM 11 MONTHS TO 13 MONTHS.

    Description of Event or Problem · 0

    APPROXIMATELY 13 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS.

    Additional Manufacturer Narrative · 1

    THE PATIENT REQUIRED REVASCULARIZATION OF THE TARGET LESION. THIS IS BEING REPORTED AS A FOLLOW-UP TO THE CLINICAL STUDY. CROSS REFERENCE MFR REPORT NUMBERS: 3009784280-2019-00529, 3009784280-2019-00531, 3009784280-2019-00532. REPORT SOURCE: FOREIGN- (B)(6)/ STUDY NAME: (B)(6)- PATIENT ID # (B)(6). PMA NUMBER IS NOT APPLICABLE. THE DEVICE IS A NON-COMMERCIAL PRODUCT WITH A CE MARK THAT WAS USED AS PART OF A CLINICAL STUDY. DURING THE INDEX PROCEDURE, THE PRODUCT WORKED AS INTENDED. THE DEVICE WAS DISCARDED, THUS NO PRODUCT EVALUATION WAS PERFORMED. PER THE IFU, RESTENOSIS IS LISTED AS A POTENTIAL COMPLICATIONS/ADVERSE EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A CLINICAL STUDY THAT DURING THE INDEX PROCEDURE ON (B)(6) 2017, FOUR STELLAREX CATHETERS WERE USED TO TREAT THE TARGET LESION OF THE RIGHT PROXIMAL, MID, AND DISTAL SFA AND POPLITEAL, P1 AND P3. APPROXIMATELY 11 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS. A SUCCESSFUL REVASCULARIZATION OF THE TARGET LESION WAS PERFORMED ON (B)(6) 2019. THE PHYSICIAN INDICATED THIS IS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596449 STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON DCB PTA CATHETER ONU SPECTRANETICS A35SX050120135 FFX17D21A

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R