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

Model Number	IAV06006008P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	03/29/2022
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 one in.Pact av access balloon was used to treat the in cannulation zone of the left arm.Approximately 3 months post procedure the patient suffered from juxta anastomotic stenosis of the brachiobasilic avf which was treated with medication and a pci.The pci was performed in the anastomosis of the left arm using a non mdt balloon.The patient recovered.The cec adjudicated the event as a clinically driven tlr intervention.The cec adjudicated the event as related to the study device and not related to the procedure.The site had commented that the treatment area is not within the target lesion of the index procedure.The cec commented that they adjudicated the event as related to the study device and as a tlr intervention because "as per core laboratory analysis, the subject did have revascularization of the target lesion.Maybe the indication was outside of the lesion, but the target lesion was touched during the procedure.This would be the reasoning for the cec adjudication¿.

• Brand Name: IN.PACT AV ACCESS
• 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: 15757945
• Report Number: 9612164-2022-04131
• Device Sequence Number: 14996103
• Product Code: ONU
• UDI-Device Identifier: 00763000232573
• UDI-Public: 00763000232573
• 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): 11/09/2022

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: 07/20/2022
• Device Model Number: IAV06006008P
• Device Catalogue Number: IAV06006008P
• Device Lot Number: 0009835623
• 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: 08/23/2022
• Initial Report FDA Received Date: 11/09/2022
• Date Device Manufactured: 07/21/2019
• 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: Other; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian