MAUDE Adverse Event Report: COVIDIEN LP EVERFLEX; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	EVD35-06-040-120
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a lower extremity arteriogram.During the procedure, the stent partially separated from the deployment device while the safety lock remained engaged.Stent and sheath removed, resulting in stent fracture and need to convert to an open procedure for primary arterial repair.Potential incompatibility of stent and cook triforce catheter.

• Brand Name: EVERFLEX
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 15502844
• Report Number: 15502844
• Device Sequence Number: 18100637
• Product Code: NIP
• UDI-Device Identifier: 00821684051344
• UDI-Public: 00821684051344
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/22/2022
• Report Date (Section F): 09/22/2022

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
• Device Model Number: EVD35-06-040-120
• Device Lot Number: B362684
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Race: White
• Date Report Sent to FDA: 09/22/2022