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

Model Number	S-50-080-120-P6
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	Pain (1994); Pseudoaneurysm (2605)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.Electronic lot history record (elhr) 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 prior to device removal the stent was not fully/entirely released from the device resulting in the stent being inadvertently removed along with the device; however this cannot be confirmed.The investigation determined a conclusive cause for the reported activation failure cannot be determined.The reported difficulties possibly caused/contributed to the reported patient effects; however a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effects of pseudoaneurysm and pain are listed in the supera peripheral stent systems instructions for use as a potential adverse effect.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 to treat a lesion in the superficial femoral artery (sfa) with moderate calcification.A 5x120mm supera stent was deployed at the target lesion without issue.Then, a 5x80mm supera stent was advanced to the target lesion to be overlapped with the initial stent that had been implanted.It was noted that the patient was in pain and moving constantly.The pain was treated with medication and it was thought that the stent was deployed.During removal of the stent system, it was observed that the stent was being removed with the delivery system.At this point fluoroscopy was used to continue the procedure.Extravasation was noted and the procedure was discontinued at the patient's request.The patient was placed in the post operative office based lab (obl) and discharged soon after.A few hours later, the patient was transported by ambulance to the hospital.At the hospital the patient presented with a pseudoaneurysm which was treated with medication.After overnight observation, the patient was discharged and is doing well.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: 20271368
• Report Number: 2024168-2024-11146
• Device Sequence Number: 3339381
• Product Code: NIP
• UDI-Device Identifier: 08717648211751
• UDI-Public: (01)08717648211751(17)251130(10)3121161
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/20/2024

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: 11/30/2025
• Device Model Number: S-50-080-120-P6
• Device Catalogue Number: S-50-080-120-P6
• Device Lot Number: 3121161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 5X120MM SUPERA STENT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown