BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

    MDR report key: 8269088 · Received January 22, 2019

    Report

    Report Number
    3006513822-2019-00006
    Event Type
    Injury
    Date Received
    January 22, 2019
    Date of Event
    December 19, 2018
    Report Date
    February 21, 2019
    Manufacturer
    C.R. BARD, INC. (GFO)
    Product Code
    ONU
    UDI-DI
    00801741123306
    PMA / PMN Number
    P130024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DESCRIPTION WAS CHANGED FROM "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 RIGHT COMMON FEMORAL ARTERY (CFA) AND RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). TREATMENT IN THE RIGHT CFA IS NOT AN APPROVED INDICATION PER THE INSTRUCTIONS FOR USE (IFU), THUS THE PHYSICIAN USED THE LUTONIX DCB OFF-LABEL. APPROXIMATELY 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT HAD WORSENING PERIPHERAL VASCULAR DISEASE (PVD) IN TARGET LIMB DUE TO REOCCLUSION. A REVASCULARIZATION WAS PERFORMED ON THE TARGET LESION, RIGHT COMMON FEMORAL ARTERY (CFA), AND RIGHT MID SFA. THE REVASCULARIZATION ON THE TARGET LESION AND RIGHT CFA (NOT TARGET LESION) INVOLVED A SCORING BALLOON AND A DCB. THE RIGHT MID SFA WAS TREATED WITH A DRUG ELUTING STENT (DES). THE HEATH CARE PROFESSIONAL (HCP) DEEMED THE REVASCULARIZATION SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE AND PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED." TO "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 RIGHT COMMON FEMORAL ARTERY (CFA) AND RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). TREATMENT IN THE RIGHT CFA IS NOT AN APPROVED INDICATION PER THE INSTRUCTIONS FOR USE (IFU), THUS THE PHYSICIAN USED THE LUTONIX DCB OFF-LABEL. APPROXIMATELY 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT'S TARGET LESION WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED ON THE TARGET LESION, RIGHT COMMON FEMORAL ARTERY (CFA), AND RIGHT MID SFA. THE REVASCULARIZATION ON THE TARGET LESION AND RIGHT CFA (NOT TARGET LESION) INVOLVED A SCORING BALLOON AND A NON-LUTONIX DCB. THE RIGHT MID SFA WAS TREATED WITH A DRUG ELUTING STENT (DES). THE HEATH CARE PROFESSIONAL (HCP) DEEMED THE REVASCULARIZATION SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE AND PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED." CORRECTED DATA: THE EVAL CODE + DESC - RESULTS CODE "213" WAS REMOVED BECAUSE THE INVESTIGATOR DEEMED THE EVENT POSSIBLY RELATED TO THE STUDY DEVICE. THE CONCLUSION HAD THE FOLLOWING SENTENCES CHANGED FROM "THE INVESTIGATOR ASSESSED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. BASED ON THE INSTRUCTIONS FOR USE (IFU), THE OCCURRENCE OF REOCCLUSION, WHICH LED TO THE WORSENING OF THE PVD, IS AN INHERENT RISK OF ANY PTA PROCEDURE, AND HAS BEEN REPORTED IN CLINICAL TRIALS OF DRUG COATED BALLOONS." TO "THE INVESTIGATOR ASSESSED THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE AND PROCEDURE. BASED ON THE INSTRUCTIONS FOR USE (IFU), THE OCCURRENCE OF REOCCLUSION IS AN INHERENT RISK OF ANY PTA PROCEDURE AND HAS BEEN REPORTED IN CLINICAL TRIALS OF DRUG COATED BALLOONS." ANALYSIS: THE SAMPLE WAS NOT RETURNED FROM THE USER FACILITY; THEREFORE, A 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 POSSIBLY RELATED TO THE STUDY DEVICE AND PROCEDURE. BASED ON THE INSTRUCTIONS FOR USE (IFU), THE OCCURRENCE OF 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 WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    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 RIGHT COMMON FEMORAL ARTERY (CFA) AND RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). TREATMENT IN THE RIGHT CFA IS NOT AN APPROVED INDICATION PER THE INSTRUCTIONS FOR USE (IFU), THUS THE PHYSICIAN USED THE LUTONIX DCB OFF-LABEL. APPROXIMATELY 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT'S TARGET LESION WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED ON THE TARGET LESION, RIGHT COMMON FEMORAL ARTERY (CFA), AND RIGHT MID SFA. THE REVASCULARIZATION ON THE TARGET LESION AND RIGHT CFA (NOT TARGET LESION) INVOLVED A SCORING BALLOON AND A NON-LUTONIX DCB. THE RIGHT MID SFA WAS TREATED WITH A DRUG ELUTING STENT (DES). THE HEATH CARE PROFESSIONAL (HCP) DEEMED THE REVASCULARIZATION SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE AND PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED FROM THE USER FACILITY; THEREFORE, A DEVICE EVALUATION IS UNABLE TO BE PERFORMED. A LOT HISTORY REVIEW THIS IS THE ONLY COMPLAINT ASSOCIATED WITH THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATES THE LOT WAS MANUFACTURED TO SPECIFICATION. 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 REOCCLUSION, WHICH LED TO THE WORSENING OF THE PVD, 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 WITH ALL RELEVANT INFORMATION. THE INFORMATION PROVIDED BY BD 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 BD.

    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 RIGHT COMMON FEMORAL ARTERY (CFA) AND RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). TREATMENT IN THE RIGHT CFA IS NOT AN APPROVED INDICATION PER THE INSTRUCTIONS FOR USE (IFU), THUS THE PHYSICIAN USED THE LUTONIX DCB OFF-LABEL. APPROXIMATELY 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT HAD WORSENING PERIPHERAL VASCULAR DISEASE (PVD) IN TARGET LIMB DUE TO REOCCLUSION. A REVASCULARIZATION WAS PERFORMED ON THE TARGET LESION, RIGHT COMMON FEMORAL ARTERY (CFA), AND RIGHT MID SFA. THE REVASCULARIZATION ON THE TARGET LESION AND RIGHT CFA (NOT TARGET LESION) INVOLVED A SCORING BALLOON AND A DCB. THE RIGHT MID SFA WAS TREATED WITH A DRUG ELUTING STENT (DES). THE HEATH CARE PROFESSIONAL (HCP) DEEMED THE REVASCULARIZATION SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE AND PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62009 LUTONIX 035 DRUG COATED BALLOON PTA CATHETER DRUG COATED BALLOON PTA CATHETER ONU C.R. BARD, INC. (GFO) 9004 GFCN0499 00801741123306

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention