BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

    MDR report key: 6826286 · Received August 29, 2017

    Report

    Report Number
    3006513822-2017-00165
    Event Type
    Injury
    Date Received
    August 29, 2017
    Date of Event
    July 26, 2017
    Report Date
    August 30, 2017
    Manufacturer
    C.R. BARD, INC. (GFO)
    Product Code
    ONU
    UDI-DI
    00801741088667
    PMA / PMN Number
    P130024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS: THE SAMPLE WAS NOT RETURNED FROM THE USER FACILITY; THEREFORE, DEVICE EVALUATION IS UNABLE TO BE PERFORMED. A LOT HISTORY REVIEW REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATES THE LOT WAS MANUFACTURED TO SPECIFICATION. CONCLUSION: THE ACTUAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. THE DHR FOUND NOTHING TO INDICATE A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THE INVESTIGATOR ASSESSED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. BASED ON THE INSTRUCTIONS FOR USE (IFU), THE OCCURRENCE OF A REOCCLUSION IS AN INHERENT RISK OF ANY PTA PROCEDURE, AND HAS BEEN REPORTED IN CLINICAL TRIALS OF DRUG COATED BALLOONS. IF ADDITIONAL INFORMATION BECOMES KNOWN TO THE MANUFACTURER, A SUPPLEMENTAL REPORT WILL BE PROVIDED WILL ALL RELEVANT INFORMATION. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    MANUFACTURER NAME HAS BEEN CORRECTED FROM C.R. BARD, INC (BASD) TO C.R. BARD, INC (GFO). MFR SITE INFORMATION HAS BEEN CORRECTED TO (B)(4). ANALYSIS: THE SAMPLE WAS NOT RETURNED FROM THE USER FACILITY; THEREFORE, DEVICE EVALUATION IS UNABLE TO BE PERFORMED. A LOT HISTORY REVIEW REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATES THE LOT WAS MANUFACTURED TO SPECIFICATION. CONCLUSION: THE ACTUAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. THE DHR FOUND NOTHING TO INDICATE A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THE INVESTIGATOR ASSESSED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. BASED ON THE INSTRUCTIONS FOR USE (IFU), THE OCCURRENCE OF A REOCCLUSION IS AN INHERENT RISK OF ANY PTA PROCEDURE, AND HAS BEEN REPORTED IN CLINICAL TRIALS OF DRUG COATED BALLOONS. IF ADDITIONAL INFORMATION BECOMES KNOWN TO THE MANUFACTURER, A SUPPLEMENTAL REPORT WILL BE PROVIDED WILL ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT POPLITEAL ARTERY. APPROXIMATELY 19 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT POPLITEAL VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT POPLITEAL ARTERY. APPROXIMATELY 19 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT POPLITEAL VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608494 LUTONIX 035 DRUG COATED BALLOON PTA CATHETER DRUG COATED BALLOON PTA CATHETER ONU C.R. BARD, INC. (GFO) 9004 GFZD0378 00801741088667

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention