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

Model Number 9010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Restenosis (4576)

Event Date 10/20/2022

Event Type  Injury  

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.Labelling 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.(expiration date: 08/2024).Device not returned.

Event Description

It was reported through the results of a clinical trial that approximately ten months and fourteen days post index procedure using a drug-coated balloon catheter, restenosis of the target lesion occurred and was successfully treated with an av access circuit reintervention.The re-intervention was successful and the outcome was resolved.The current status of the patient is not provided.

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.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: (expiration date: 08/2024).H11: section a through f ¿ the information provide 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.

Event Description

It was reported through the results of a clinical trial that ten months and fourteen days post index procedure using a drug-coated balloon catheter, the subject had an adverse event of stenosis of the cephalic vein and was successfully treated with an av access circuit reintervention.It was further reported that standard percutaneous transluminal angioplasty and a drug coated balloon along with a charger balloon were used for treatment.The re-intervention was successful and the outcome was resolved.Furthermore, approximately one year and one month post index procedure, the subject had an adverse event of pancreatic adenocarcinoma and the subject reportedly expired.The primary cause of death was pancreatic adenocarcinoma which was not related to the device, not related to the procedure, and not related to av access circuit.

• Brand Name: LUTONIX 035AV DRUG COATED PTA DILATION CATHETER
• Type of Device: 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: 15803196
• MDR Text Key: 303705788
• Report Number: 3006513822-2022-00041
• Device Sequence Number: 1
• Product Code: PRC
• UDI-Device Identifier: 00801741135354
• UDI-Public: (01)00801741135354
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/16/2023

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
• Device Operator: Health Professional
• Device Model Number: 9010
• Device Catalogue Number: LX3575560V
• Device Lot Number: GFFT0686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 11/17/2023
• Supplement Dates FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White