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

Catalog Number UNK SUPERA

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

Patient Problem Unspecified Vascular Problem (4441)

Event Date 01/01/2020

Event Type  Death  

Event Description

It was reported via a research article that 437 patients with femoro-popliteal atherosclerotic disease were enrolled in the study.Treatment was either implanting supera stent or undergoing open bypass surgery of the femoro-popliteal segment.The aim of the study was to compare femoro-popliteal bypass and interwoven nitinol stenting for long occlusions of the femoropopliteal segment.A total of 113 patients had the supera stent implanted with no reported procedure issues.As primary endpoints primary patency, primary-assisted patency and secondary patency were calculated.For secondary endpoints major adverse cardiovascular events, major adverse limb events, primary sustained clinical improvement and survival were documented.Post procedure follow-ups identified the following adverse patient effects potentially related to the supera stent: death, thrombosis, dissection, hematoma, wound infection, myocardial infarction, restenosis, medical intervention, surgical intervention, and amputation.The article conclusion was that a nonselective endovascular strategy can allow for regular successful treatment of femoro-popliteal lesions longer than 25 cm using interwoven nitinol stents.Additional details can be found in the attached article, "bypass versus interwoven nitinol stents for long femoro-popliteal occlusions: a propensity matched analysis".

Manufacturer Narrative

B2: date of death estimated.B3: date of event estimated.D4: the udi is unknown due to the part/lot number was not provided.D6a - implant date estimated.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.The reported patient effect of death is listed in the supera peripheral stent system instructions for use as a potential adverse effect of peripheral percutaneous intervention.A conclusive cause for the reported death 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.The additional adverse patient effects referenced in b5 are captured under a separate medwatch report.

• 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: 18221500
• MDR Text Key: 329165174
• Report Number: 2024168-2023-13139
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• 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
• Date Manufacturer Received: 11/15/2023
• 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): Death
• Patient Age: 65 YR
• Patient Sex: Male