MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT 018 PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOO; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS

Catalog Number	IPU04010013P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Pain (1994); Skin Discoloration (2074); Stenosis (2263)
Date of Event	09/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During the index procedure an in.Pact 018 balloon was used to treat the patient.Post procedure patient suffered ischemic toe stenosis of left lower extremity.Subject presented to emergency department with left toe pain and discoloration.Patient admitted to vascular surgery.Patient underwent left lower extremity angiogram, balloon angioplasty of the superficial femoral artery and selective catheterization of popliteal artery.Patient was hospitalized for approximately 5 weeks and discharged.Patient underwent amputation of left toe, deep vein arterialization, balloon angioplasty and stenting of the superficial femoral artery.Patient recovered.
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.

• Brand Name: IN.PACT 018 PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOO
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS
• 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: 23959997
• Report Number: 9612164-2026-00049
• Device Sequence Number: 9528494
• Product Code: ONU
• UDI-Device Identifier: 00763000291242
• UDI-Public: (01)00763000291242(17)260410(10)0012221458
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P140010
• 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): 01/05/2026

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: 04/10/2026
• Device Catalogue Number: IPU04010013P
• Device Lot Number: 0012221458
• 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: 12/10/2025
• Initial Report FDA Received Date: 01/05/2026
• Date Device Manufactured: 04/10/2024
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Hispanic
• Patient Race: White