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 Problems Perforation of Vessels (2135); Stenosis (2263)

Event Date 01/01/2017

Event Type  Injury  

Event Description

It was reported via a research article that 341 patients who had rutherford class 2 to 6 peripheral artery disease and underwent endovascular therapy (evt) with either covered stent-graft (csg) or supera peripheral stent (sps) for femoropopliteal lesions.The aim of this study was to compare the safety and efficacy between csg and sps in calcified femoropopliteal lesions in clinical practice.The primary outcome measure was freedom from loss of primary patency and the secondary outcome measures included freedom from target lesion revascularization (tlr), limb salvage (freedom from major amputation), and overall survival (freedom from all-cause mortality).Color doppler ultrasound was performed routinely at 6 and 12 months after evt to evaluate vascular patency.Post-procedure follow-ups reported the following adverse patient effects potentially related to the supera stents: death, restenosis, vascular intervention, vessel rupture after post-dilatation and major amputation (surgery).The article conclusion was that in patients with bilaterally calcified femoropopliteal lesions, 1-year primary patency was not significantly different between treatments using csg and sps after the propensity score matching.The interaction effect analysis suggested that csg might have a lower restenosis rate than sps in the subgroup with long calcification.Additional details can be found in the attached article, "retrospective multicenter comparison between viabahn covered stent-grafts and supera interwoven nitinol stents for endovascular treatment in severely calcified femoropopliteal artery disease: the armadillo study (adjusted retrospective comparison of scaffolds in calcified lesions)".

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.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 effects of stenosis and vessel perforation are listed in the supera peripheral stent system instructions for use as potential adverse effects of peripheral percutaneous intervention.A conclusive cause for the reported stenosis and perforation, 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 "retrospective multicenter comparison between viabahn covered stent-grafts and supera interwoven nitinol stents for endovascular treatment in severely calcified femoropopliteal artery disease: the armadillo study (adjusted retrospective comparison of scaffolds in calcified lesions)".

• 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: 18287732
• MDR Text Key: 329994498
• Report Number: 2024168-2023-13617
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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

• Date FDA Received: 12/07/2023
• 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): Hospitalization; Required Intervention; Disability
• Patient Age: 76 YR
• Patient Sex: Male