BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

    MDR report key: 6294991 · Received February 1, 2017

    Report

    Report Number
    3006513822-2017-00012
    Event Type
    Injury
    Date Received
    February 1, 2017
    Date of Event
    September 29, 2016
    Report Date
    January 15, 2019
    Manufacturer
    C.R. BARD, INC. (GFO)
    Product Code
    ONU
    UDI-DI
    00801741088759
    PMA / PMN Number
    P130024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A.4 THE WEIGHT AND WEIGHT UNITS WERE FILLED IN WITH 135 AND LBS, RESPECTIVELY. B.5 THE EVENT DESCRIPTION WAS CHANGED FROM " IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 5 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA 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 NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED." TO "IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESIONS LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND RIGHT POPLITEAL ARTERY. APPROXIMATELY 5 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA AND POPLITEAL VESSELS WERE REPORTEDLY REOCCLUDED VIA DUPLEX ULTRASOUND (DUS) IMAGING. A REVASCULARIZATION WAS PERFORMED AND THE HEALTH CARE PROFESSIONAL (HCP) DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICES OR PROCEDURE. THE SAMPLES WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED." B.6 THE RELEVANT TESTS AND LAB DATA WERE UPDATED FROM "UNKNOWN" TO "ON (B)(6) 2016, DUS IMAGING INDICATED TARGET LESION WAS PATENT. ON (B)(6) 2016, DUS IMAGING INDICATED TARGET LESIONS WERE OCCLUDED. ON (B)(6) 2016, REINTERVENTION WAS PERFORMED ON BOTH TARGET LESIONS IN THE RIGHT SFA." B.7 THE OTHER RELEVANT HISTORY WAS CHANGED FROM "ALTHOUGH REQUESTED, THE PATIENT WEIGHT IS NOT AVAILABLE." TO "PAST MEDICAL HISTORY INCLUDES: HYPERTENSION, FORMER SMOKER, PREVIOUS INTERVENTION ON THE TARGET LESION INVOLVING PTA AND PLACEMENT OF A BARE METAL STENT ON (B)(6) 2015, RUTHERFORD CLASS II IN RIGHT LEG." CORRECTED DATA: D.4 THE UDI NO. WAS CHANGED FROM "(B)(4)." E.2 THE COMPLAINT HEALTH PROF? WAS CHANGED FROM "NO" TO YES." H.6 THE EVAL CODE AND DESC SECTION WAS UPDATED TO ALIGN WITH FDA GUIDANCE EFFECTIVE JULY 6TH, 2018. THE METHOD CODES "3263 AND 3317" WERE CHANGED TO "4115,3331, AND 4110." THE RESULTS CODE "213" WAS ADDED. THE CONCLUSION CODE "92" WAS CHANGED TO "4310." H3 ANALYSIS: THE SAMPLE(S) WERE NOT RETURNED TO THE USER FACILITY; THEREFORE, DEVICE EVALUATIONS ARE UNABLE TO BE PERFORMED. A LOT HISTORY REVIEW REVEALED THIS IS THE ONLY REOCCLUSION COMPLAINT ASSOCIATED WITH THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THE LOT WAS MANUFACTURED TO SPECIFICATION. CONCLUSION: THE ACTUAL SAMPLES WERE 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 · 0

    IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESIONS LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND RIGHT POPLITEAL ARTERY. APPROXIMATELY 5 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA AND POPLITEAL VESSELS WERE REPORTEDLY REOCCLUDED VIA DUPLEX ULTRASOUND (DUS) IMAGING. A REVASCULARIZATION WAS PERFORMED AND THE HEALTH CARE PROFESSIONAL (HCP) DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICES OR PROCEDURE. THE SAMPLES WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURERS REPORT NUMBER IS 3006513822-2017-00013.

    Additional Manufacturer Narrative · 1

    ANALYSIS: THE SAMPLE(S) WERE NOT RETURNED TO THE USER FACILITY; THEREFORE, DEVICE EVALUATIONS ARE UNABLE TO BE PERFORMED. A LOT HISTORY REVIEW REVEALED THIS IS THE ONLY REOCCLUSION COMPLAINT ASSOCIATED WITH THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THE LOT WAS MANUFACTURED TO SPECIFICATION. CONCLUSION: THE ACTUAL SAMPLES WERE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 5 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA 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 NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURERS REPORT NUMBER IS 3006513822-2017-00013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77301 LUTONIX 035 DRUG COATED BALLOON PTA CATHETER DRUG COATED BALLOON PTA CATHETER ONU C.R. BARD, INC. (GFO) 9004 GFZI2854 00801741088759

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention