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

Model Number	S-55-040-120-P6
Medical Device Problem Codes	Stretched (1601); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.2017- incorrect removalna.
Event or Problem Description
It was reported, the procedure was to treat a mildly calcified and tortuous lesion in the left popliteal artery.The lesion was pre-dilated with a 5.5 and a 6.0mm non-abbott balloon.The 5.5x40mm supera self expanding stent system (sess) was advanced to the target lesion without issue and deployment initiated.After approximately 2/3 of the stent was deployed, the stent could not be fully deployed.The thumb slide was able to turn, but the stent was not deploying.Troubleshooting steps were performed, including rotating the handle and gently pushing back and forth.The stent was able to fully deploy.However, it was noted it elongated approximately 1cm.The stent was deployed in the target lesion with the elongated part reaching 1cm into the distal superficial femoral artery (sfa).The delivery system was not removed under fluoroscopy.There was no clinically significant delay in the procedure.And no adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported difficult or delayed activation was unable to be replicated in a testing environment due to the condition of the returned device.The reported stretched stent was unable to be confirmed as the stent was not returned.Reportedly, the delivery system was not removed under fluoroscopy.It should be noted that the supera peripheral stent system instructions for use (ifu) states: under fluoroscopy, remove the device from the guide wire and evaluate the improved luminal quality of the treated area.The deviation of the instructions for use does not appear to have caused/contributed to the reported difficulties.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 from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the distal sheath of the delivery system was entrapped or bent in the mildly calcified and tortuous lesion anatomy such that the ratchet was unable to properly/fully engage the stent resulting in the reported deployment difficulty/ difficult or delayed activation.Manipulation of the device including rotating the handle and gently pushing back and forth in attempts to fully deploy the stent resulted in the reported stretched stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16733842
• Report Number: 2024168-2023-03776
• Device Sequence Number: 6843421
• Product Code: NIP
• UDI-Device Identifier: 08717648226069
• UDI-Public: 08717648226069
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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: 09/30/2024
• Device Model Number: S-55-040-120-P6
• Device Catalogue Number: S-55-040-120-P6
• Device Lot Number: 2102661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 81 KG