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

Model Number	9004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Insufficient Information (4580)
Date of Event	04/18/2023
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 (expiry date: 01/2025).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.
Event or Problem Description
It was reported through the results of a clinical trial that eleven months and eight days post index procedure using a drug-coated balloon catheter in the axillary vein via the right upper arm access, the subject reportedly expired, and the primary cause of death was unknown at this time.Reportedly, there have been no documented device deficiencies and no adverse events were reported, and the relationship of the death with the device, procedure and arteriovenous access circuit is unknown.
Event or Problem Description
It was reported through the results of a clinical trial that eleven months post index procedure completion using a drug-coated balloon catheter in the axillary vein via the right upper arm, the subject developed a serious adverse event of hypoxic respiratory failure, and the outcome of the serious adverse event was fatal which resulted in death.However, the adverse event was not related to the index procedure, not related to the study device and not related to the arteriovenous (av) access circuit.It was further reported that eleven months and thirteen days post index procedure completion, the subject had a serious adverse event of right upper extremity fistula clot which required an additional arteriovenous access circuit reintervention due to access thrombosis in the upper arm.Reportedly, mechanical thrombectomy was performed to treat the access thrombosis.The treatment reintervention was successful, and the outcome of the serious adverse event was resolved.Furthermore, the subject reportedly expired, and the primary cause of death was acute hypoxic respiratory failure.Reportedly, there have been no documented device deficiencies were reported, and the relationship of the death was not related to the study device, was not related to the procedure, and was not related to the arteriovenous access circuit.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.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.It was later reported that the location of the fistula clot did not involve the target lesion that was previously treated using the lutonix balloon.The site reported that the event was not related to the lutonix device or the procedure but related to the arteriovenous access circuit.Based on the available information, the investigation is unconfirmed for the reported failure.Based upon the available information, the definitive root cause of the fistula clot is related to the arteriovenous access circuit.The patient's death was determined to be due to hypoxic respiratory failure and was not related to the device.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 01/2025), g3, h6 (method).H11: b3, b5, h1, h6 (patient, result, conclusion).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: 18226134
• Report Number: 3006513822-2023-00046
• Device Sequence Number: 14787857
• Product Code: ONU
• UDI-Device Identifier: 00801741123269
• UDI-Public: (01)00801741123269
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• 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): 01/11/2024

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: 9004
• Device Catalogue Number: LX351306605F
• Device Lot Number: GFFX1579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• 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; Death
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White