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

Model Number S-55-120-120-P6

Device Problems Difficult to Remove (1528); Difficult or Delayed Activation (2577); Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2020

Event Type  malfunction  

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 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.

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
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11067265
• MDR Text Key: 223595067
• Report Number: 2024168-2020-10913
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226144
• UDI-Public: 08717648226144
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE, V18, SHEATH: 6FR X 50 MM.