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

Model Number	S-60-150-120-P6
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Pseudoaneurysm (2605); Swelling/ Edema (4577)
Date of Event	09/24/2024
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.Date of event is estimated as (b)(6) 2025.The udi number is not known as the part and lot number were not provided.Literature attachment: article titled: "huge pseudoaneurysm in severe calcified popliteal artery occlusion early after supera stent implantation.
Event or Problem Description
It was reported in a research article case summary that the patient presented with left sided claudication.Imaging revealed occlusion of the distal superficial femoral artery to the mid popliteal artery with calcification.Intravascular ultrasound (ivus) was used to guide parallel guide wires to the calcified lesion.A 6x150 mm supera self expanding stent was deployed.Three weeks later, the patient developed severe pain and edema in the left lower extremity.Imaging revealed a large pseudoaneurysm and tearing of the stent implantation site at the edge of the vessel.The stent was floating within the aneurysm.A non-abbott stent graft was deployed to fully cover and block blood flow to the aneurysm.There was no stent fracture.Additional information can be found in the article "huge pseudoaneurysm in severe calcified popliteal artery occlusion early after supera stent implantation".
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 query of the complaint handling database for the reported lot revealed there is no indication of a lot level product quality issue.A conclusive cause for the reported patient's effects, and the relationship to the product, if any, cannot be determined.The treatment appears to be related to the operational context of the procedure.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.B1: correction: product problem removed.B3: date of event corrected from 1/21/2025 to 9/24/2024.D4: model # correction from unk supera to s-60-150-120-p6.D4: catalog # correction from unk supera to s-60-150-120-p6.D4: lot# correction: from unknown to 3112261.D4: primary udi number correction: from unknown to (b)(4).H6: medical device problem code 4003 was removed and 2993 was added.
Event or Problem Description
Subsequent to the initially filed report it was reported the supera stent and an additional 6x150 mm supera stent were implanted on (b)(6) 2024 and symptoms began on (b)(6) 2024.There was no report of stent migration in the article or via the photos in the article.The non-abbott stent was implanted on (b)(6) 2024.

• 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: 21350468
• Report Number: 2024168-2025-01497
• Device Sequence Number: 7741012
• Product Code: NIP
• UDI-Device Identifier: 08717648211843
• UDI-Public: (01)08717648211843(17)251031(10)3112261
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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: 10/31/2025
• Device Model Number: S-60-150-120-P6
• Device Catalogue Number: S-60-150-120-P6
• Device Lot Number: 3112261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2023
• 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; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female