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

Model Number	S-50-040-120-P6
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the endovascular therapy (evt) procedure was to treat a de novo, moderately calcified vessel in the superficial femoral artery (sfa).The vessel diameter was 5.0mm and the lesion length was 180mm.The evt was started by tai (trans ankle intervention) and a non-abbott stent was implanted.However, stent recoil was significant due to part of the calcification and insufficient stent expansion was confirmed.Atherectomy was not used.The 5.0x40mm supera self-expanding stent system (sess) was implanted in the non-abbott stent and there was no resistance during advancement.There was heavy resistance during withdrawal because the tip of the supera stent got stuck with the non-abbott implanted stent and force was applied that the tip of the delivery system separated.It was confirmed under fluoroscopy that the stent emerged from the sheath and was fully released.There was no waste noted to the deployed stent or proximal end of lesion.The thumb slide fully retracted to the start position and both the system and deployment levers were locked prior to removal.The separated tip was removed from the anatomy by using a snare device.There was no adverse patient sequela and there was no reported significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The stent remains in patient and the delivery system was discarded.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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, there was heavy resistance during withdrawal because the tip of the supera stent got stuck with the non-abbott implanted stent and force was applied and the tip of the delivery system separated.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 advancement or stent deployment the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.In this case, the tip of the supera stent got stuck with the non-abbott implanted stent and the force was required to try to release the stent.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the previously implanted non-abbott stent resulted in the reported difficult to remove.Manipulation of the device ultimately resulted in the reported material separation.The treatment appears to be related to the operational context of the procedure as reportedly the separated tip was removed from the anatomy by using a snare device.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: 12879681
• Report Number: 2024168-2021-10828
• Device Sequence Number: 4950102
• Product Code: NIP
• UDI-Device Identifier: 08717648211737
• UDI-Public: 08717648211737
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: S-50-040-120-P6
• Device Catalogue Number: S-50-040-120-P6
• Device Lot Number: 0090361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 11/26/2021
• Supplement Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2020
• 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: LIFE STENT 6.0×200
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown