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

Model Number	S-55-100-120-P6
Medical Device Problem Codes	Difficult to Remove (1528); Activation Failure (3270)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	01/31/2025
Type of Reportable Event	Serious Injury
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 was to treat a lesion in the right superficial femoral artery (sfa) with heavy calcification.The 5.5x100mm supera self expanding stent system (sess) was advanced to the target lesion and the stent was attempted to be deployed; however, the stent would only partially deploy.The stent was noted to be stuck in the sheath.Therefore, the sheath was pulled back and the stent was noted to be in the patient's left groin and partially outside the patient.The patient was transferred to the hospital and cutdown surgery was performed to remove the stent.Bruising and discomfort was noted by the patient.The patient was discharged from the hospital on (b)(6) 2025.There as no adverse patient sequela.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.It is possible that the distal sheath of the delivery system was bent in the heavy calcified anatomy such that the ratchet was unable to properly/fully engage the stent resulting in the reported activation/deployment failure; however this cannot be confirmed.The investigation determined a conclusive cause for the reported activation failure cannot be determined.During removal of the compromised device, interaction with anatomy and/or other devices resulted in the reported difficult to remove (sheath was pulled back and the stent was noted to be in the patient's left groin and partially outside the patient).As reported, cutdown surgery was performed to remove the stent.The reported difficulties possibly caused/contributed to the reported patient effect(s), however a conclusive cause for the reported patient effect(s) and the relationship to the product, if any, cannot be determined.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: 21471859
• Report Number: 2024168-2025-02110
• Device Sequence Number: 8840569
• Product Code: NIP
• UDI-Device Identifier: 08717648226120
• UDI-Public: (01)08717648226120(17)260731(10)4080161
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 04/17/2025

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: 07/31/2026
• Device Model Number: S-55-100-120-P6
• Device Catalogue Number: S-55-100-120-P6
• Device Lot Number: 4080161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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: Female