MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT AV ACCESS; DRUG-COATED PERIPHERAL TRANSLUMINAL ANGIOPLAST

Catalog Number	IAV08006008P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stenosis (2263); Insufficient Information (4580)
Date of Event	09/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
During the index procedure 4 in.Pact av access balloon catheters were used to treat the venous outflow, brachiocephalic/superior vena cava (svc) stent and the cephalic arch of the right arm.Approximately 11 months post procedure the patient suffered from venous outflow restenosis of the avf.The patient presented for a routine fistulogram.Imaging showed 50% restenosis of the venous outflow (target lesion).The sponsor commented that there was target lesion restenosis.The event was successfully treated with a plain balloon and drug coated balloon angioplasty using non mdt devices.There were no immediate complications noted.The patient was also treated with medication.The patient recovered.

• Brand Name: IN.PACT AV ACCESS
• Common Device Name: DRUG-COATED PERIPHERAL TRANSLUMINAL ANGIOPLAST
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 22862151
• Report Number: 9612164-2025-04127
• Device Sequence Number: 9230971
• Product Code: PRC
• UDI-Device Identifier: 00763000232658
• UDI-Public: (01)00763000232658(17)250529(10)0011236924
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P190008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/21/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/29/2025
• Device Catalogue Number: IAV08006008P
• Device Lot Number: 0011236924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2025
• Initial Report FDA Received Date: 08/21/2025
• Date Device Manufactured: 05/30/2022
• 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: Other; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian