MAUDE Adverse Event Report: ABBOTT VASCULAR INC. SUPERA; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	S-45-080-120-P6
Medical Device Problem Codes	Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for analysis.The reported tip material separation was able to be confirmed.The reported stretched stent was unable to be replicated in a testing environment due to the condition of the returned device (stent not returned).Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that after stent deployment during device removal inadvertent interaction resulted in the tip of the device to become caught on the deployed stent; thus resulting in the reported stretched stent and ultimately resulting in the reported/noted tip material separation.As reported, an attempt was made to snare the separated nose cone but was unsuccessful.During the snaring attempt the nose cone fell down into the peroneal artery.No further intervention was performed.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Attachment medwatch report #(b)(4).
Event or Problem Description
Subsequent to the initial report being filed, a medsun report was received stating the following: [describe the event or problem: during the deployment of the stent to the patient's left popliteal artery, the nose cone of the stent sheared off in the artery.What was the original intended procedure? left leg peripheral angiography.What problem did the user have: device malfunction - that is, the device did not do what it was supposed to do; device failed (e.G.Broke, couldn't get it to work or stopped working); therapies being used on the patient at the time of the event that may have caused or contributed to the event: not applicable;] no additional information was provided.
Event or Problem Description
It was reported that the procedure was to treat in-stent restenosis in the popliteal artery.The 4.5x80mm supera self-expanding stent system (sess) was advanced to the target lesion and the stent was implanted without issue.The handle was relocked and the delivery system was removed; however, when the delivery system was pulled out of the sheath the nose cone was noted to be missing.No resistance was noted during removal.Imaging was performed and the stent was noted to have elongated from the popliteal to the sfa; however, the stent remained open.The separated nose cone was noted to be in the popliteal artery.Therefore, an attempt was made to snare the separated nose cone but was unsuccessful.During the snaring attempt the nose cone fell down into the peroneal artery.No further intervention was performed.There was no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

• Brand Name: SUPERA
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 23268204
• Report Number: 2024168-2025-11052
• Device Sequence Number: 5290576
• Product Code: NIP
• UDI-Device Identifier: 08717648225963
• UDI-Public: (01)08717648225963(17)260930(10)4102561
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: S-45-080-120-P6
• Device Catalogue Number: S-45-080-120-P6
• Device Lot Number: 4102561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Hispanic
• Patient Race: White