MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC; EVERFLEX PROTEGE, SELF-EXPANDING PERIPHERAL STENT SYSTEM

Model Number	PRB35-06-120-120
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	03/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Stent (protégé) implanted into pt's left arm av graft.During procedure, surgeon noticed that part of the stent was lodged in pt.Cutdown on the cephalic vein needed to remove stent insertion device.

• Brand Name: MEDTRONIC
• Common Device Name: EVERFLEX PROTEGE, SELF-EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): MEDTRONIC; plymouth MN
• MDR Report Key: 10876924
• Report Number: 10876924
• Device Sequence Number: 3285075
• Product Code: NIP
• UDI-Device Identifier: 00821684059968
• UDI-Public: (01)00821684059968(17)2
• Combination Product (Y/N): Y
• Initial Reporter State: HI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/26/2020
• Report Date (Section F): 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2021
• Device Model Number: PRB35-06-120-120
• Device Catalogue Number: PRB35-06-120-120
• Device Lot Number: A628708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/26/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 66
• Date Report Sent to FDA: 03/26/2020