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

Model Number	S-65-100-120-P6
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the superficial femoral artery (sfa) that was mildly calcified.The supera stent system was advanced to the target lesion without resistance and the stent was deployed; however, while removing the delivery system, the stent was removed as well.It was suspected that fluoroscopy was not used when removing the delivery system.There was no adverse patient effect and no clinically significant delay in the procedure.The procedure was aborted as the access site had been lost.The patient will be monitored until another procedure is performed.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.Reportedly, the supera self-expanding stent system (sess) was not removed under fluoroscopy.It should be noted that the supera peripheral stent system instructions (ifu) for use, states: under fluoroscopy, remove the device from the guide wire and evaluate the improved luminal quality of the treated area.It is undetermined if the deviation of the ifu caused/contributed to the reported difficulties.As there was no reported damage noted to the device during the inspection prior to use, the investigation determined the reported difficulty appears to be related to circumstances of the procedure as it is likely that interactions with the mildly calcified anatomy resulted in the ratchet being unable to properly engage and release the stent from the delivery system; thus, resulting in reported activation failure/ deployment failure.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• 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: 14597380
• Report Number: 2024168-2022-05958
• Device Sequence Number: 5426843
• Product Code: NIP
• UDI-Device Identifier: 08717648226281
• UDI-Public: 08717648226281
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 06/30/2022

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: 12/31/2022
• Device Model Number: S-65-100-120-P6
• Device Catalogue Number: S-65-100-120-P6
• Device Lot Number: 1011461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2021
• 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: 68 YR
• Patient Sex: Male