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

Model Number	IAV08008008P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	07/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During the index procedure two in.Pact av access pta balloon catheters were used to treat an in cannulation zone lesion located in the right arm.Approximately 3 months post procedure patient suffered from 75% restenosis in the cannulation zone segment.The event was treated with revascularization in the tandem proximal non cannulation zone segment and arterial inflow in the right arm.Patient recovered.
Additional Manufacturer Narrative
Update received 19 may 2025: during the index procedure the right arm venous anastomosis was treated.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.

• 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: 12574960
• Report Number: 9612164-2021-03815
• Device Sequence Number: 1101256
• Product Code: ONU
• UDI-Device Identifier: 00763000232665
• UDI-Public: 00763000232665
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 06/12/2025

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: 08/19/2022
• Device Model Number: IAV08008008P
• Device Catalogue Number: IAV08008008P
• Device Lot Number: 0009879526
• 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: 09/10/2021
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 06/12/2025
• Date Device Manufactured: 08/20/2019
• 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: 43 YR
• Patient Sex: Female
• Patient Weight: 105 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American