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	Vascular Dissection (3160)
Date of Event	05/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.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.A definitive root cause could not be determined based upon the available information.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.Expiry date: 05/2023.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 after some time post index procedure using a drug-coated balloon catheter, peripheral artery dissection occurred and was successfully treated.The outcome was resolved.The current status of the patient is not provided.
Event or Problem Description
It was reported through the results of a clinical trial that after some time post index procedure using a drug-coated balloon catheter, in the cephalic arch, the subject had an adverse event of dissection of cephalic arch and was treated with an av access circuit reintervention.Reportedly, repeated standard percutaneous transluminal angioplasty was performed and a stent graft was deployed.The re-intervention was successful and the outcome was resolved.It was further reported that one year, six months and twenty-eight days post the index procedure, the subject had an adverse event of acute respiratory failure.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.Reportedly, the subject expired and the primary cause of death was mentioned as acute respiratory failure with hypoxia.However, the relationship of the death was not related to the study device, not related to the index procedure and not related to the arteriovenous (av) access circuit.
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.Based on the available information, the investigation is inconclusive for the reported dissection.It was later reported that the patient experienced hypoxia and acute respiratory failure.The site reported that the patient's death was not related to the lutonix device or the procedure and not related to the arteriovenous access circuit.Based upon the available information, the definitive root cause for the dissection could not be determined.The patient's death was determined to be due to hypoxic respiratory failure and was not related to the device or the av access circuit.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.

• 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 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: 14683062
• Report Number: 3006513822-2022-00018
• Device Sequence Number: 4855786
• Product Code: PRC
• UDI-Device Identifier: 00801741135491
• UDI-Public: (01)00801741135491
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P170003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2024

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: LX3575960V
• Device Lot Number: GFFR0612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2021
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American