MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. LIFESTENT; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	5F060403CS
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The patient had a self-expanding stent placed in the right superficial femoral artery.At that time, patient had 100% stenosis of the mid-right superficial femoral artery.Patient was taken back to the catheterization lab because there was 100% stenosis of the mid to distal right superficial femoral artery.A 5f sheath and a glidewire advantage® guidewire placed in the distal right peroneal artery were used.Balloon angioplasty was performed in the mid to distal right superficial femoral artery, the popliteal artery, and then the peroneal artery.Angiography demonstrated a dissection flap just distal to the previously placed stent in the right superficial femoral artery and this was covered with a lifestent® 5f self-expanding vascular stent.It was immediately apparent after deployment of the stent that the distal portion of the stent delivery system was retained within the vessel due to malfunction of the stent delivery system.A 3.2 mm goose neck snare delivery system was used to retrieve the retained foreign body in the right superficial femoral artery and retracted through the sheath, nothing was left behind.The retained (broken off) portion is approximately 8-9 inches long.

• Brand Name: LIFESTENT
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w. 3rd st; tempe AZ 85281
• MDR Report Key: 12727238
• Report Number: 12727238
• Device Sequence Number: 4550369
• Product Code: NIP
• UDI-Device Identifier: 00801741120152
• UDI-Public: (01)00801741120152
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/29/2021
• Report Date (Section F): 10/29/2021

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 Model Number: 5F060403CS
• Device Catalogue Number: 5F060403CS
• Device Lot Number: ANEQ0233
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 54
• Date Report Sent to FDA: 10/29/2021