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

Model Number	S-70-060-120-P6
Medical Device Problem Codes	Stretched (1601); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure performed was to treat a de novo, heavily calcified, moderately tortuous left superficial femoral artery that is 50% stenosed.Access to the lesion was via ipsilateral antegrade approach and predilated with an unspecified 7mm balloon.During deployment of the 7.0x60mm supera peripheral self-expanding stent (ses) over a 0.014 guide wire, elongation occurred.It was believed the stent length exceeded the selected size, the second lock was released and the stent was implanted.During removal of the supera system, the stent was inadvertently pulled into the guiding sheath, ultimately removing both the guiding sheath and stent.A non-abbott 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 returned for analysis.The reported stretched stent and the reported activation failure was unable to be replicated in a testing environment due to the condition of the returned device.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 similar incidents from this lot.As there was no damage noted to the device during the inspection prior to use, it is possible that during stent implantation interaction with the heavily calcified, moderately tortuous and 50% stenosed anatomy and/or pre-dilatation was not enough causing the stent to stretch/elongate; however this cannot be confirmed.The investigation determined a conclusive cause for the reported stretched stent cannot be determined.During removal it is likely the tip of the device got caught on the deployed stent resulting in the noted kinked tip lumen and the noted tip jacket separation resulting in the stent inadvertently being pulled into the guiding sheath; thus resulting in the reported activation failure.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.
Event or Problem Description
Subsequently, device analysis identified that the tip jacket was separated from the base of the tip.No additional information was provided.

• 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: 23872832
• Report Number: 2024168-2025-12212
• Device Sequence Number: 17252801
• Product Code: NIP
• UDI-Device Identifier: 08717648344268
• UDI-Public: (01)08717648344268(17)261231(10)5013161
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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 Model Number: S-70-060-120-P6
• Device Catalogue Number: S-70-060-120-P6
• Device Lot Number: 5013161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2025
• 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 Sex: Unknown