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

Model Number	S-75-100-120-P6
Medical Device Problem Codes	Stretched (1601); Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left superior femoral artery (sfa) with mild tortuosity, mild calcification and 80% stenosis.A 6 fr 6mm sheath was used in a 7.5 mm vessel and a non-abbott balloon was used to pre-dilate the lesion.The 7.5x100mm supera self expanding stent system (sess) was advanced to the lesion.During deployment, the thumbslide was being moved back and forth and the stent stopped deploying; therefore, the stent was repositioned by rotating and shaking the handle and pulling the deployment shaft straight until resistance was met.The stent then engaged and the stent was ultimately deployed, but a portion of the stent remained in the target lesion, and a portion remained in healthy tissue and was noted elongated.There was no other device used to treat the lesion.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 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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the mildly tortuous, mildly calcified and 80% stenosed anatomy prevented the shaft lumens from moving freely resulting in the reported thumbwheel difficulties and the reported difficulty deploying the stent.Interaction with the anatomy (reported tight area) and /or manipulation of the device during attempts to deploy the stent ultimately resulted in the reported stretched/elongated 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: 17089327
• Report Number: 2024168-2023-06070
• Device Sequence Number: 6069286
• Product Code: NIP
• UDI-Device Identifier: 08717648294501
• UDI-Public: 08717648294501
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/08/2023

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: 10/31/2024
• Device Model Number: S-75-100-120-P6
• Device Catalogue Number: S-75-100-120-P6
• Device Lot Number: 2111661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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: 6FR SHEATH
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 109 KG