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

Model Number	S-50-020-120-P6
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a restenosis lesion at several different previously implanted stents within the superficial femoral artery (sfa) and mid popliteal with a 5mm vessel diameter.The vessel was prepared using a non-abbott atherectomy device as well as pre-dilatation with a 5mm jade balloon dilatation catheter (bdc) to 12atms for 30secs.A 5x20mm supera peripheral self-expanding stent (ses) was advanced through a 6fr sheath to a lesion in the mid popliteal, and the deployment lock was unlocked and the thumb slide was advanced to the most distal position on the handle.However, during withdrawal, under fluoroscopy, it was noted that the stent was not fully deployed from the delivery catheter and instead was inadvertently pulled and deployed in the proximal sfa with no part of the stent in the target lesion.Therefore, a 5mm armada 18 bdc was used to post-dilate and fully appose the supera stent to the vessel wall, and the procedure was completed with simple balloon angioplasty.There was no adverse patient sequela nor clinically significant delay in procedure reported.No additional information was provided.
Additional Manufacturer Narrative
The device 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.The product was not returned to abbott vascular for analysis.There was no damage noted to the device during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as reportedly the physician did not ensure the stent was fully deployed prior to removing the delivery system from the anatomy.The treatment appears to be related to the operational context of the procedure as a 5mm armada 18 bdc was used to post-dilate and fully appose the supera stent to the vessel wall, and the procedure was completed with simple balloon angioplasty.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.

• 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: 22105748
• Report Number: 2024168-2025-05482
• Device Sequence Number: 7022872
• Product Code: NIP
• UDI-Device Identifier: 08717648211720
• UDI-Public: (01)08717648211720(17)250930(10)3102561
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 05/29/2025

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: 09/30/2025
• Device Model Number: S-50-020-120-P6
• Device Catalogue Number: S-50-020-120-P6
• Device Lot Number: 3102561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2023
• 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