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

Model Number	S-45-060-120-P6
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A supera 4.5x60mm self expanding stent was advanced and deployed in the p1/p2 popliteal segment.When trying to resheath the delivery catheter, the delivery component became entrapped in the p2 segment of the stent and fractured.A 5.0mm coronary balloon was attempted to advance over the 0.014 miracle bros wire to expand the stent around the retained fragment.This was unsuccessful.Next a 0.014 fielder xt was attempted to wire around the retained fragment to get a balloon next to the delivery component, which was unsuccessful.Finally, and amplatz 9.0mm gooseneck snare was advanced and attempted to entrap the device - which was unsuccessful.At this point, the decision was made to abort the procedure and call vascular surgery for consultation for fragment removal.The wires were removed.The sheath was exchanged for standard 6fx12cm sheath which was sutured into place.The stent system was removed two days later.

• Brand Name: SUPERA
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): ABBOTT VASCULAR; 3200 lakeside drive; santa clara CA 95054
• MDR Report Key: 8168775
• Report Number: 8168775
• Device Sequence Number: 11186715
• Product Code: NIP
• UDI-Device Identifier: 08975370026245
• UDI-Public: (01)08975370026245
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2018
• Report Date (Section F): 12/06/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: S-45-060-120-P6
• Device Catalogue Number: S-45-060-120-P6
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2018
• 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: Hospitalization; Required Intervention
• Patient Weight: 99
• Date Report Sent to FDA: 12/06/2018