MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 42055120-080

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Stenosis (2263)

Event Date 11/21/2023

Event Type  Injury  

Event Description

It was reported that two supera stents (5.5x120 mm and 5.5x80 mm) were implanted on (b)(6), 2023.On (b)(6), 2023, the patient presented with severe claudication of the right leg and an angiogram confirmed a stent re-stenosis had occurred.No treatment has been provided at this time.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect(s) of stenosis and pain is listed in the supera peripheral stent systems instructions for use as a known patient effect(s) of coronary procedures.A cine was received and reviewed by an abbott vascular clinical specialist: the radiographic images provided do show the reported occlusion in what appears to be the distal section of the previously deployed supera located in the distal superficial femoral artery (sfa).A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.B3 - date of event updated from 3/24/2023 to 11/21/2023.

Event Description

Subsequently to the initial filed emdr reported additional information was received: it was reported that both supera stents were implanted in the femoral popliteal artery.No additional information was provided.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 18440305
• MDR Text Key: 331859215
• Report Number: 2024168-2024-00118
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 42055120-080
• Device Lot Number: 2091661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 5.5X80 MM SUPERA
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 80 KG