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

Model Number	S-45-120-120-P6
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the superficial femoral artery (sfa) with mild calcification, mild tortuosity and 90% stenosis.After pre dilating the 4.2mm vessel with a non-abbott balloon at 6 atmospheres (atm) for three minutes.The 4.5x120 supera self expanding stent system (sess) was attempted to be deployed; however, the deployment lock was still locked.The deployment lock was then unlocked and the thumbwheel was being slide but the stent stopped deploying after one- third (partially).The delivery system was forcibly removed under fluoroscopy.Another 4.5x120 supera stent was used to complete the procedure.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 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 incidents from this lot.Reportedly, the 4.5x120 supera self-expanding stent system (sess) was attempted to be deployed; however, the deployment lock was still locked.It should be noted that during stent deployment after thumb slide advancement no longer deploys the stent the supera peripheral stent system instructions for use (ifu) states: step 7.Rotate the deployment lock to the unlocked position.Then step 9 states: under fluoroscopy, slowly advance the thumb slide to the distal most position on the handle.The deployment lock was eventually rotated to the unlocked position.Additionally, the delivery system was forcibly removed under fluoroscopy.It should be noted that the supera peripheral stent system instructions for use ifu states: should unusual resistance be felt at any time during stent system removal, the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.Although it was noted that resistance was noted during removal, the force applied during removal of the device seemed to be a reasonable clinical response to the difficulties.It is possible that the distal sheath of the delivery system was entrapped or bent in the mildly calcified, mildly tortuous and 90% stenosed anatomy such that the ratchet was unable to properly/fully engage the stent resulting in the reported deployment difficulty/activation failure; however this cannot be confirmed.Additionally, it is possible interaction with the mildly calcified, mildly tortuous and 90% stenosed anatomy and/or other devices resulted in the reported difficult to remove the compromised device; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.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: 16678692
• Report Number: 2024168-2023-03497
• Device Sequence Number: 14870449
• Product Code: NIP
• UDI-Device Identifier: 08717648226007
• UDI-Public: 08717648226007
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2023

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: 07/31/2024
• Device Model Number: S-45-120-120-P6
• Device Catalogue Number: S-45-120-120-P6
• Device Lot Number: 2081561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 0.018 V18 GUIDE WIRE BOSTON SCIENTIFIC.
• Patient Sex: Unknown