MAUDE Adverse Event Report: ABBOTT VASCULAR, INC. SUPERA; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	S-65-040-120-P6
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
There was a flow-limiting dissection in the distal common femoral artery (cfa) and a 5.5mm x 80 supera stent was deployed.We then went to overlap a 6.5 x 40 supera stent with this.The intended location was for the right common femoral artery in the mid to distal segment.At the point of near complete deployment, the unlocking and unleashing mechanism from the supera shaft was stuck.It did not work.In the process of pulling the carcass of the stent out, the supera stent also migrated north to the aortic bifurcation.We were able to retrieve the distal plastic nose ring of the supera.

• Brand Name: SUPERA
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): ABBOTT VASCULAR, INC.; 26531 ynez rd.; temecula CA 92591
• MDR Report Key: 8581848
• Report Number: 8581848
• Device Sequence Number: 3236747
• Product Code: NIP
• UDI-Device Identifier: 08717648226229
• UDI-Public: (01)08717648226229
• 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): 04/30/2019
• Report Date (Section F): 04/30/2019

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: S-65-040-120-P6
• Device Catalogue Number: S-65-040-120-P6
• Device Lot Number: 8082261
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 84
• Date Report Sent to FDA: 04/30/2019