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

Model Number S-65-040-120-P6

Device Problems Migration (4003); Activation Problem (4042)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/23/2019

Event Type  malfunction  

Event 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
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): ABBOTT VASCULAR, INC.; 26531 ynez rd.; temecula CA 92591
• MDR Report Key: 8581848
• MDR Text Key: 144132037
• Report Number: 8581848
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226229
• UDI-Public: (01)08717648226229
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29930 DA
• Patient Weight: 84