BEUDAMED
    FDA Adverse Event Death Summary report: N

    STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON

    MDR report key: 6919235 · Received October 5, 2017

    Report

    Report Number
    3009784280-2017-00036
    Event Type
    Death
    Date Received
    October 5, 2017
    Date of Event
    October 10, 2014
    Report Date
    September 13, 2017
    Manufacturer
    SPECTRANETICS
    Product Code
    ONU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S CAUSE OF DEATH IS UNKNOWN, HOWEVER IT IS UNLIKELY RELATED TO THE DEVICE OR PROCEDURE SINCE IT WAS APPROXIMATELY 16-MONTHS POST THE INDEX PROCEDURE. THIS IS BEING REPORTED AS A FOLLOW-UP TO THE CLINICAL STUDY. PATIENT INFORMATION REGARDING RELEVANT TESTS OR LABORATORY DATA IS UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. IT IS UNLIKELY THAT THE PACLITAXEL DRUG CAUSED OR CONTRIBUTED TO THE DEATH SINCE THE PATIENT EXPIRED APPROXIMATELY 16-MONTHS POST THE INDEX PROCEDURE. UDI AND PMA NUMBERS ARE NOT APPLICABLE. THIS DEVICE WAS USED IN CLINICAL APPLICATION PRIOR TO BEING AVAILABLE IN THE US. FOREIGN- (B)(6) / STUDY NAME: ILLUMENATE GLOBAL- PATIENT ID #(B)(6). COMBINATION PRODUCT IS APPLICABLE. DURING THE INDEX PROCEDURE, THE PRODUCT WORKED AS INTENDED, THUS NO PRODUCT EVALUATION WAS REQUIRED. PER THE IFU, DEATH IS LISTED AS A POTENTIAL COMPLICATIONS/ADVERSE EVENTS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT UNDERWENT AN INDEX PROCEDURE OF A 50 MM, 100% STENOTIC DE NOVO LESION OF THE DISTAL SFA. THE LESION WAS PRE-DILATED USING A 3 X 40 MM PTA BALLOON AND INFLATED TO 12 ATM, RESULTING IN RESIDUAL 70% STENOSIS. THEN, A 4 X 80 MM STELLAREX BALLOON WAS INFLATED TO 18 ATM FOR 2 MINUTES, RESULTING IN A RESIDUAL 10% STENOSIS. DURING THE SAME PROCEDURE, A 120 MM, 100% STENOTIC DE NOVO LESION OF THE DISTAL POPLITEAL WAS TREATED. THE LESION WAS PRE-DILATED USING A 3 X 40 MM PTA BALLOON AND INFLATED TO 12 ATM, RESULTING IN RESIDUAL 70% STENOSIS. THEN, A 4 X 120 MM STELLAREX BALLOON WAS INFLATED TO 16 ATM FOR 2 MINUTES, RESULTING IN RESIDUAL 10% STENOSIS. NO COMPLICATIONS REPORTED, THE PATIENT WAS DISCHARGED PER PLAN. ON (B)(6) 2016, THE PATIENT EXPIRED. THE PATIENT WAS ON DIALYSIS, HOWEVER THE CAUSE OF DEATH REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694521 STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON DCB PTA CATHETER ONU SPECTRANETICS A35DC04008013IO 14F0340801

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other