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

Model Number	IAV08004008P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stenosis (2263); Insufficient Information (4580)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
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.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 two in.Pact av access balloon and two non mdt balloons.During a fourth procedure, the anastomosis of the left arm was treated using two non mdt balloons.During a fifth procedure the in cannulation zone and central vein of the left arm were treated with one in.Pact admiral balloon and four non mdt balloons.During a sixth procedure, the in cannulation zone of the left arm was treated with 6 non mdt balloons.During a seventh procedure, the central vein of the left arm was treated with two non mdt balloons.Approximately 17 months post the index procedure, 14 months post the second procedure, 11 months post the third procedure, 10 months post the fourth procedure, 7 month post the fifth procedure, 6 months post the sixth procedure and 3 months post the seventh procedure the patient suffered from venous outflow restenosis of the avf.The patient presented for a routine fistulogram.Angiographic imaging showed restenosis of the venous outflow (non index lesion).The event was treated with a drug coated balloon and plain balloon angioplasty.The venous outflow and central vein of the left arm was treated with one in.Pact av access balloon and 3 non mdt balloons.The patient was also treated with medication.No immediate complications were noted.The patient was discharged home the same day.The patient recovered.The cec adjudicated the event as related to the index device and not related to the procedure or paclitaxel.Both the cec and sponsor assessed the event as associated with the target lesion.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 17779625
• Report Number: 9612164-2023-04256
• Device Sequence Number: 15090965
• Product Code: ONU
• UDI-Device Identifier: 00763000232641
• UDI-Public: 00763000232641
• 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): 09/20/2023

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: 08/27/2022
• Device Model Number: IAV08004008P
• Device Catalogue Number: IAV08004008P
• Device Lot Number: 0009895229
• 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: 08/22/2023
• Initial Report FDA Received Date: 09/20/2023
• Date Device Manufactured: 08/28/2019
• 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; Other
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian