MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT AV ACCESS; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Catalog Number IAV08006008P

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

Patient Problem Stenosis (2263)

Event Date 12/05/2023

Event Type  Injury  

Event Description

During the index procedure a in.Pact av access was used to treat the left arm cephalic arch.Two in.Pact av access were used to treat the cephalic arch. approximately 6 months post procedure patient suffered restenosis cephalic arch. restenosis avf at index target lesion treated with stent graft and medtronic dcb for recalcitrant stenosis with improvement post pta and stenting. patient recovered.

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.

Manufacturer Narrative

Additional information: the investigator assessed the event as probably related to the device and paclitaxel and causally related to the re-intervention procedure.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
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• 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: 19094834
• MDR Text Key: 339980584
• Report Number: 9612164-2024-01755
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00763000232658
• UDI-Public: 00763000232658
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: IAV08006008P
• Device Lot Number: 0011577308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 05/16/2024
• Date Device Manufactured: 01/06/2023
• 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: 31 YR
• Patient Sex: Female
• Patient Weight: 127 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American