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

Model Number	S-65-150-120-P6
Medical Device Problem Codes	Material Separation (1562); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for analysis.The reported material separation was able to be confirmed.The reported difficult or delayed activation was unable to be replicated in a testing environment as it was based on operational circumstances.The reported stretched stent was unable to be replicated in a testing environment as the stent was not returned for analysis.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.Reportedly, resistance was noted during withdrawal and was force applied.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 removal, the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.The force applied during removal of the device seemed to be a reasonable clinical response to the difficulties.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 during deployment the tip/cone of the device inadvertently got caught on the deployed stent.Manipulation of the compromised device using force resulted in the reported material separation/noted tip/tip lumen/tip jacket separations and ultimately resulted in the reported stretched stent resulting in the reported difficult or delayed activation.As reported, the separated tip was removed via snare and the procedure was completed with a non-abbott stent.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
It was reported that the procedure was performed to treat a lesion in the distal popliteal to proximal superficial femoral artery(sfa).Contra-lateral access to the lesion was gained using a 6fr sheath that was introduced in the right groin.Following access to the lesion, the vessel was pre-treated with thrombectomy and orbital atherectomy.Three supera perpherial self-expanding stents were successfully implanted with no issues.A 6mm non-abbott balloon was used for pre-dilatation of the last target vessel, and the 6.5x150mm supera self expanding stent was attempted to be deployed in the sfa with the distal portion of the 6fr sheath remaining in the common femoral artery.Halfway through deployment, the delivery catheter cone was noted to be caught on the deployed stent, subsequently causing the tip of delivery catheter to separate.The remaining potion delivery catheter and partially deployed stent were attempted to be removed causing the stent to be inadvertently stretch.The stent was deployed in the external iliac with only part of the stent remaining at the target lesion.The separated tip was removed via snare and the procedure was completed with a non abbott stent.There were no adverse patient sequela and no clinical delay was reported.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: 23078386
• Report Number: 2024168-2025-09932
• Device Sequence Number: 15968590
• Product Code: NIP
• UDI-Device Identifier: 08717648226328
• UDI-Public: (01)08717648226328(17)260430(10)4052861
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/17/2025

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: 04/30/2026
• Device Model Number: S-65-150-120-P6
• Device Catalogue Number: S-65-150-120-P6
• Device Lot Number: 4052861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2024
• 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 Sex: Unknown