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

Model Number	S-55-120-120-P6
Medical Device Problem Codes	Difficult to Remove (1528); Difficult or Delayed Activation (2577); Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the device is not returning.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 performed to treat a de novo lesion with moderate calcification in the superior femoral artery (sfa) with vessel diameter of 5.5mm.The lesion was distal to a previously implanted non-abbott restenosed stent.A 6fr x 50 cm sheath was placed.The stent restenosis was dilated by an unspecified balloon.A 5.5 x 120 mm supera self-expanding stent system (sess) was attempted to be implanted at the de novo lesion overlapping with the previously implanted non-abbott stent; however, the tip of the supera got caught [unable to advance further or remove].The sess was manipulated and the sess was finally freed and the stent deployed.Resistance with the thumbslide was also noted on deployment of the stent.The supera stent was ultimately successfully implanted at the target lesion and the sess removed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.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 similar incidents.The investigation determined the cause for the reported difficulty to advance, difficulty to remove, delayed activation, and physical resistance are related to the circumstances of the procedure.It is likely that the tip or outer sheath of the supera system became stuck with a strut of the previously implanted stent during insertion.The act of pulling the system pulled the tip out allowing for normal operation and deployment.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: 11067265
• Report Number: 2024168-2020-10913
• Device Sequence Number: 2651899
• Product Code: NIP
• UDI-Device Identifier: 08717648226144
• UDI-Public: 08717648226144
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2020

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: 12/31/2021
• Device Model Number: S-55-120-120-P6
• Device Catalogue Number: S-55-120-120-P6
• Device Lot Number: 0010261
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 12/30/2020
• 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: GUIDE WIRE, V18, SHEATH: 6FR X 50 MM.