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

Catalog Number UNK SUPERA

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Pain (1994); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 09/01/2017

Event Type  Injury  

Event Description

It was reported via a research article that 128 patients with atherosclerotic disease were treated with a supera stent in the femoral popliteal region.The aim of the study was to evaluate the durability and long-term patency of the supera stent to treat severe femoral popliteal lesions.All lesions were pre-dilated.Some of the lesions were pre-dilated using smaller diameter balloons than the required 1:1 vessel preparation, due to smaller diameter, (sub)occlusive lesions.Post-dilatation was done in all stents.As primary endpoints patency rates and freedom from target lesion revascularization (tlr) were calculated after 12 and 24 months.No significant patency differences were observed based on calcification rate.Post-procedure follow-ups reported the following adverse patient effects potentially related to the supera stents: death (within 66 months), occlusion, ischemia, claudication, thrombectomy (thrombus), bypass surgery, minor and major amputation.The article conclusion was that endovascular treatment of femoropopliteal disease with supera stent is safe, even in highly calcified lesions.Patency rates and freedom from target lesion revascularization (tlr) are acceptable in a real-life population.Additional details can be found in the attached article, "self-expanding interwoven nitinol stent in severe femoropopliteal arterial disease.Real life results of the supera peripheral stent system".

Manufacturer Narrative

B3: date of event is estimate.D4.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.D6a - implant date is estimate.H6: medical device problem code 2017 failure to follow steps / instructions.The device was not returned for evaluation.A review of the lot history record could not be conducted because the part and lot number was not provided.Reportedly, some of the lesions were pre-dilated using smaller diameter balloons than the required 1:1 vessel preparation, due to smaller diameter, (sub)occlusive lesions.It should be noted that the supera peripheral stent system instructions for use (ifu) states: prepare the vessel/duct utilizing standard angioplasty technique using a balloon size greater then the stent outer diameter.Precaution: the vessel/duct size after pre-dilatation should be at least the size of the stent diameter.If recommended vessel/duct diameter cannot be gained, optimal stent deployment may not be achieved and revised stent sizing should be considered.The reported patient effects of thrombosis, occlusion and pain are listed in the supera peripheral stent system ifu as potential adverse effects of peripheral percutaneous intervention.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The treatment(s) appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional adverse patient effect of death referenced in b5 is captured under a separate medwatch report.Attachment: article titled, "self-expanding interwoven nitinol stent in severe femoropopliteal arterial disease.Real life results of the supera peripheral stent system".

• Brand Name: SUPERA
• 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: 18288220
• MDR Text Key: 329994338
• Report Number: 2024168-2023-13645
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SUPERA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 76 YR
• Patient Sex: Male