MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 035AV DRUG COATED PTA DILATION CATHETER; DRUG COATED BALLOON PTA CATHETER

Model Number	9010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	12/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4 (expiration date: 06/2025).H11: section a through f - 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.H3 other text: device not returned.
Event or Problem Description
It was reported through the results of a clinical trial that two months and twenty-seven days post index procedure using a drug coated balloon catheter in the cephalic vein at cephalic arch, the subject developed a serious adverse event of stenosis in cephalic arch and subclavian vein in arteriovenous fistula which required additional arteriovenous access circuit reintervention.It was further reported that the target lesion had ninety percent initial stenosis and zero percent final residual stenosis.It was also reported that the new lesion within the access circuit had ninety percent initial stenosis and thirty percent final residual stenosis.Standard percutaneous transluminal balloon angioplasty procedure was performed to treat restenosis.The treatment re-intervention was successful, and so a new access was not created.Reportedly, the outcome of serious adverse event was resolved.The current status of the patient is unknown.
Event or Problem Description
It was reported through the results of a clinical trial that two months and twenty-seven days post an index procedure completion using a drug coated balloon catheter in the cephalic vein at cephalic arch, the subject had serious adverse event of stenosis in cephalic arch and subclavian vein in the arteriovenous fistula which required an arteriovenous access circuit reintervention due to elevated venous pressures.The target lesion had ninety percent initial stenosis and zero percent final residual stenosis.Standard percutaneous transluminal balloon angioplasty procedure was performed to treat elevated venous pressures.The treatment re-intervention was successful, and the outcome of serious adverse event was resolved.It was further reported that five months and eighteen days post an index procedure completion, the subject had serious adverse event of stenosis of subclavian vein outflow in the arteriovenous fistula which required an arteriovenous access circuit re-intervention due to diminished or abnormal thrill, pulsatility, and prolonged bleeding.Imaging from re-intervention_1 analyzed by core lab identified that the target lesion was involved with seventy-two percent diameter stenosis prior to the re-intervention and fifteen percent diameter stenosis after re-intervention.Standard percutaneous transluminal balloon angioplasty procedure was performed to treat diminished or abnormal thrill, pulsatility, and prolonged bleeding.The treatment re-intervention was successful and the outcome of serious adverse event was resolved.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ the information provided by bd represents all 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.H3 other text : device not returned.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ the information provided by bd represents all 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.
Event or Problem Description
It was reported through the results of a clinical trial that two months and twenty-seven days post an index procedure completion using a drug coated balloon catheter in the cephalic vein at cephalic arch, the subject had serious adverse event of stenosis in cephalic arch and subclavian vein in arteriovenous fistula due to elevated venous pressures which required an arteriovenous access circuit reintervention.The target lesion had ninety percent initial stenosis and zero percent final residual stenosis.Standard percutaneous transluminal balloon angioplasty procedure was performed to treat elevated venous pressures.Treatment re-intervention was successful, no new access created, and the outcome of serious adverse event was resolved.It was further reported that five months and ten days post an index procedure completion, imaging from re-intervention_1 analyzed by core lab identified the target lesion was involved with seventy-two percent diameter stenosis prior to the re-intervention and fifteen percent diameter stenosis after re-intervention.It was also reported that five months and eighteen days post an index procedure completion, the subject had serious adverse event of stenosis of subclavian vein outflow in arteriovenous fistula due to diminished or abnormal thrill, pulsatility, and prolonged bleeding which required an arteriovenous access circuit re-intervention.Standard percutaneous transluminal balloon angioplasty procedure was performed to treat diminished or abnormal thrill, pulsatility, and prolonged bleeding.Treatment re-intervention was successful, no new access created, and the outcome of serious adverse event was resolved.Furthermore, nine months and ten days post an index procedure completion, the subject had serious adverse event of stenosis of cephalic arch in arteriovenous fistula due to elevated venous pressures which required an arteriovenous access circuit reintervention.The target lesion had seventy-two percent initial stenosis and twenty-seven percent final residual stenosis.Standard percutaneous transluminal angioplasty procedure was performed to treat elevated venous pressures.Treatment re-intervention was successful, no new access created, and the outcome of serious adverse event was resolved.The current status of the patient is unknown.

• Brand Name: LUTONIX 035AV DRUG COATED PTA DILATION CATHETER
• Common Device Name: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18490710
• Report Number: 3006513822-2023-00051
• Device Sequence Number: 3666240
• Product Code: PRC
• UDI-Device Identifier: 00801741135460
• UDI-Public: (01)00801741135460(11)230721(17)250612(10)GFHR0974
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P170003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2025
• Device Model Number: 9010
• Device Catalogue Number: LX3575860V
• Device Lot Number: GFHR0974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: 04/03/2024; 09/19/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 04/06/2024; 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White