MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number	S-65-040-120-P6
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was treat a heavily calcified de novo superior femoral artery (sfa).A 6.5x40mm supera self-expanding stent system (sess) was successfully implanted.During removal with fluoroscopy of the stent delivery system some resistance was met with a non-abbott y-connector.The tip separated but remained on the guide wire and was removed as a single unit.There was no adverse patient effect and no significant clinically delay.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional analysis was performed on the returned device.The tip separation was confirmed.The difficult to remove could not be confirmed due to the condition of the device.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.The investigation determined that the cause of the difficulty removing, and separation is related to the circumstances of the procedure.The device was not tested due to the condition of the device.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10459884
• Report Number: 2024168-2020-07159
• Device Sequence Number: 14271319
• Product Code: NIP
• UDI-Device Identifier: 08717648226229
• UDI-Public: 08717648226229
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2020

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 Expiration Date: 08/31/2020
• Device Model Number: S-65-040-120-P6
• Device Catalogue Number: S-65-040-120-P6
• Device Lot Number: 8092561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CHEVALIER FLOPPY GUIDE WIRE; SHEATHLESS LC 55CM GUIDE CATHETER