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

Model Number	S-50-080-120-P6
Medical Device Problem Codes	Stretched (1601); Difficult or Delayed Activation (2577); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.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 reported from this lot.The investigation was unable to determine a cause for the reported difficulties.It is possible that anatomical conditions contributed to the reported difficulties.The deployment issues, slight elongation and stacking of the stent could have been caused from the distal shaft restricted within the lesion which was described as 90% stenosed; however, this cannot be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat an eccentric de novo moderately calcified mid superficial femoral artery that was 90% stenosed.The lesion was dilated using a 5x40mm non-abbott balloon at 14 atmospheres (atm) and a 5x40mm non-abbott hp balloon at 20 atm.Then a 5x80mm supera stent was attempted to deploy, but the stent implant only partially deployed although the thumbslide was able to move during the attempted deployment.Thus, the deployment lock was unlocked, the thumbslide moved, but the stent still failed to fully deploy the last 2 cm of the implant.Finally, the shaft was pulled in an attempt to deploy and the rest of the stent implant, which was ultimately successful and deployed.The delivery system was removed under fluoroscopy.Once implanted it was noted that the distal part of the implanted stent was shortened from the first half of deployment, and the proximal part of implanted stent was elongated from the pulling of the shaft.Overall, the implanted stent was slightly short in comparison to the lesion.There was no patient effects and no clinically significant delay.No additional information was provided.

• 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: 11426852
• Report Number: 2024168-2021-01772
• Device Sequence Number: 3945399
• Product Code: NIP
• UDI-Device Identifier: 08717648211751
• UDI-Public: 08717648211751
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2021

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: 08/31/2021
• Device Model Number: S-50-080-120-P6
• Device Catalogue Number: S-50-080-120-P6
• Device Lot Number: 9091161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1