BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

    MDR report key: 7371415 · Received March 26, 2018

    Report

    Report Number
    3006513822-2018-00063
    Event Type
    Injury
    Date Received
    March 26, 2018
    Date of Event
    February 26, 2018
    Report Date
    July 27, 2018
    Manufacturer
    C.R. BARD, INC. (GFO)
    Product Code
    ONU
    UDI-DI
    00801741122941
    PMA / PMN Number
    P130024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: PRODUCT CLASSIFICATION CODE HAS BEEN CHANGED FROM "PRC" TO "ONU." THE PMA/510(K)# HAS BEEN CHANGED FROM "P170003" TO "P130024." THE SAMPLE WAS NOT RETURNED FROM THE USER FACILITY; THEREFORE, A DEVICE EVALUATION IS UNABLE TO BE PERFORMED. A LOT HISTORY REVIEW REVEALED THERE IS ONE ADDITIONAL REOCCLUSION 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 THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE, PROCEDURE, AND AV ACCESS CIRCUIT. 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.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: THE EVAL CODES + DESC WERE CHANGED TO ALIGN WITH FDA GUIDANCE OF NEW CODES TO BE USED FOR THE EVALUATION, METHODS AND CONCLUSION. THE FOLLOWING EVALUATION CODES WERE CHANGED "3263, 3317" TO "4115, 3331, 4110." THE FOLLOWING CONCLUSION CODE WAS CHANGED FORM "92" TO "4310." THE CONCLUSION HAD THE FOLLOWING SENTENCE CHANGED FROM "THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE, PROCEDURE AND AV ACCESS CIRCUIT." TO "THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE, AND DEFINITELY RELATED TO THE INDEX PROCEDURE AND AV ACCESS CIRCUIT." ADDITIONAL INFORMATION: THE EVENT DESCRIPTION WAS CHANGED TO INCLUDE THE SUBSEQUENT REVASCULARIZATION AND ASSESSMENT FROM THE PHYSICIAN "A REVASCULARIZATION WAS PERFORMED WITH A LUTONIX DCB AND THE HCP DEEMED IT WAS SUCCESSFUL. APPROXIMATELY 4 MONTHS AFTER THE INDEX PROCEDURE, THE TARGET LESION HAD REPORTEDLY REOCCLUDED AGAIN. THE HCP DID ANOTHER REVASCULARIZATION VIA SURGICAL REVISION TO THE CEPHALIC VEIN, WHICH NO LUTONIX DEVICES WERE USED, AND IT WAS DEEMED SUCCESSFUL. THERE IS AN ASSOCIATED MANUFACTURER'S REPORT NUMBER, 3006513822-2018-00128, FOR THE SECOND REVASCULARIZATION PROCEDURE. APPROXIMATELY 7 MONTHS AFTER THE INDEX PROCEDURE, THE VESSEL CONTAINING THE TARGET LESION WAS OCCLUDED. THE SITE REPORTED PUNCTURE PROBLEMS WERE ALSO PRESENT, AND IT WAS ALLEGED THAT THERE WERE PROBLEMS WITH THE CEPHALIC VEIN FROM THE BEGINNING. A REVASCULARIZATION WAS PERFORMED INVOLVING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND IT WAS DEEMED SUCCESSFUL BY THE HCP. THE INVESTIGATOR ASSESSED THAT THE ONGOING EVENT OF REOCCLUSION WAS POSSIBLY RELATED TO THE LUTONIX STUDY DEVICE, AND DEFINITELY RELATED TO THE INDEX PROCEDURE AND TO THE AV ACCESS CIRCUIT. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED." THE SAMPLE WAS NOT RETURNED FROM THE USER FACILITY; THEREFORE, A DEVICE EVALUATION IS UNABLE TO BE PERFORMED. A LOT HISTORY REVIEW REVEALED THERE IS ONE ADDITIONAL REOCCLUSION 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 THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE, AND DEFINITELY RELATED TO THE INDEX PROCEDURE AND AV ACCESS CIRCUIT. 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 CEPHALIC VEIN OUTFLOW OF THE LEFT FOREARM AV FISTULA. APPROXIMATELY 3 MONTHS AFTER THE INDEX PROCEDURE, THE TARGET LESION WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE, PROCEDURE, AND AV ACCESS CIRCUIT. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 CEPHALIC VEIN OUTFLOW OF THE LEFT FOREARM AV FISTULA. APPROXIMATELY 3 MONTHS AFTER THE INDEX PROCEDURE, THE TARGET LESION WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED WITH A LUTONIX DCB AND THE HCP DEEMED IT WAS SUCCESSFUL. APPROXIMATELY 4 MONTHS AFTER THE INDEX PROCEDURE, THE TARGET LESION HAD REPORTEDLY REOCCLUDED AGAIN. THE HCP DID ANOTHER REVASCULARIZATION VIA SURGICAL REVISION TO THE CEPHALIC VEIN, WHICH NO LUTONIX DEVICES WERE USED, AND IT WAS DEEMED SUCCESSFUL. THERE IS AN ASSOCIATED MANUFACTURER'S REPORT NUMBER, 3006513822-2018-00128, FOR THE LUTONIX DCB USED IN THE FIRST REVASCULARIZATION PROCEDURE. APPROXIMATELY 7 MONTHS AFTER THE INDEX PROCEDURE, THE VESSEL CONTAINING THE TARGET LESION WAS OCCLUDED. THE SITE REPORTED PUNCTURE PROBLEMS WERE ALSO PRESENT, AND IT WAS ALLEGED THAT THERE WERE PROBLEMS WITH THE CEPHALIC VEIN FROM THE BEGINNING. A REVASCULARIZATION WAS PERFORMED INVOLVING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND IT WAS DEEMED SUCCESSFUL BY THE HCP. THE INVESTIGATOR ASSESSED THAT THE ONGOING EVENT OF REOCCLUSION WAS POSSIBLY RELATED TO THE LUTONIX STUDY DEVICE, AND DEFINITELY RELATED TO THE INDEX PROCEDURE AND TO THE AV ACCESS CIRCUIT. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    ANALYSIS: THE SAMPLE WAS NOT RETURNED FROM THE USER FACILITY; THEREFORE, A DEVICE EVALUATION IS UNABLE TO BE PERFORMED. A LOT HISTORY REVIEW REVEALED THERE IS ONE ADDITIONAL REOCCLUSION 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 THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE, PROCEDURE, AND AV ACCESS CIRCUIT. 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. 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.

    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 CEPHALIC VEIN OUTFLOW OF THE LEFT FOREARM AV FISTULA. APPROXIMATELY 3 MONTHS AFTER THE INDEX PROCEDURE, THE TARGET LESION WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE, PROCEDURE, AND AV ACCESS CIRCUIT. 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
    212472 LUTONIX 035 DRUG COATED BALLOON PTA CATHETER DRUG COATED BALLOON PTA CATHETER ONU C.R. BARD, INC. (GFO) 9004 GFAX0755 00801741122941

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention