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

Model Number	9010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Restenosis (4576)
Date of Event	01/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through results of a clinical trial that three weeks and four days post index procedure using a drug-coated balloon catheter, the subject developed adverse event elevated venous pressure in arteriovenous fistula, a stenosis in mid cephalic and cephalic which required additional surgical intervention.It was further reported that two months and twenty-two days post index procedure, the subject had adverse event stenosis in mid cephalic fistula due to decreased access blood flow and elevated venous pressures which required additional surgical intervention.Furthermore, the subject had target lesion restenosis in cephalic vein with maximum initial stenosis of fifty percent.Reportedly, both the adverse events were not related to device, possibly related to procedure, and definitely related to av access circuit.Standard percutaneous transluminous angioplasty was used for treatment.Treatment re-intervention was successful, no new access created, and the patient recovered with final residual stenosis of zero percent.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records was 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: 07/2022) 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 results of a clinical trial that three weeks and four days post an index procedure using a drug-coated balloon catheter, the subject had an adverse event of elevated venous pressure in arteriovenous fistula, a stenosis in mid cephalic and cephalic which required arteriovenous access circuit reintervention.It was further reported that two months and twenty-two days after index procedure, the subject had an adverse event of stenosis in mid cephalic fistula due to decreased access blood flow and elevated venous pressures which required arteriovenous access circuit reintervention.It was also reported that the subject had target lesion restenosis in cephalic vein with maximum initial stenosis of fifty percent.However, both the adverse events were not related to device, possibly related to procedure, and definitely related to av access circuit.Standard percutaneous transluminous angioplasty was used for treatment.Treatment re-intervention was successful, no new access created, and the subject recovered with final residual stenosis of zero percent.Furthermore, one year, one month, and seventeen days after index procedure, the subject had an adverse event of major bleeding over fistula access site.In addition, one year, one month, and eighteen days after index procedure, right tunneled internal jugular vein central venous catheter was inserted to the subject.Apparently, one year, one month, and twenty-three days after index procedure, the subject underwent surgery for ligation of dialysis fistula.Evidently, one year, three months, and twenty-eight days after index procedure, a new left radiocephalic arteriovenous graft was created.Reportedly, the outcome of the serious adverse event was resolved.The current status of the patient is unknown.
Additional Manufacturer Narrative
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: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.B5, d4 (expiration date: 07/2022).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.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA 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: 17198794
• Report Number: 3006513822-2023-00019
• Device Sequence Number: 5540704
• Product Code: PRC
• UDI-Device Identifier: 00801741135514
• UDI-Public: (01)00801741135514
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 06/14/2024

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 Model Number: 9010
• Device Catalogue Number: LX35751040V
• Device Lot Number: GFFS0504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2021
• 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: 48 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Native Hawaiian Or Other Pacific Islander