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

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

Patient Problems Stenosis (2263); Unspecified Tissue Injury (4559)

Event Date 07/20/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

During the index procedure one in.Pact av access pta balloon catheter was used to treat the venous outflow in the left arm.Approximately 47 months post index procedure patient suffered from restenosis of the left avf.It was reported that juxta-anastomotic stenosis occurred post angioplasty with a 6mm medtronic balloon.The event was treated with medication and pci.Patient recovered.

• Brand Name: IN.PACT
• Type of Device: 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12553654
• MDR Text Key: 273991152
• Report Number: 9612164-2021-03741
• Device Sequence Number: 1
• Product Code: ONU
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/30/2021
• 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): Other; Required Intervention
• Patient Age: 58 YR