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

Model Number	IAV07004008P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	11/15/2022
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 catheter was used to treat the in cannulation zone of the left arm.During a second procedure, the anastomosis of the left arm was treated using a non mdt balloon.During a third procedure, the central vein and the anastomosis of the left arm were treated with one in.Pact av access balloon and one non mdt balloon each.During a fourth procedure, two non mdt balloons were used to treat the anastomosis of the left arm.Approximately 11 months post index procedure, 8 months post the second procedure, 4 months post the third procedure and 3 months post the fourth procedure, the patient suffered from restenosis of the cannulation zone of the brachio-basilic avf.Angiography showed areas of restenosis in the cannulation zone (index treated lesion) and restenosis of the central vein.The event was treated with a percutaneous intervention of the in cannulation zone and central vein of the left arm using one in.Pact admiral balloon catheter, four non mdt balloons and a fogarty embolectomy catheter.The patient recovered.The ae was assessed as possibly related to an underlying condition or disease.

• 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: 15958012
• Report Number: 9612164-2022-04686
• Device Sequence Number: 5574191
• Product Code: ONU
• UDI-Device Identifier: 00763000232610
• UDI-Public: 00763000232610
• 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): 12/12/2022

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: 08/11/2022
• Device Model Number: IAV07004008P
• Device Catalogue Number: IAV07004008P
• Device Lot Number: 0009867690
• 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: 11/16/2022
• Initial Report FDA Received Date: 12/12/2022
• Date Device Manufactured: 08/12/2019
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian