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 01/01/2021

Event Type  Death  

Manufacturer Narrative

B3: date of event has been estimated.The device was not returned for evaluation.A review of the lot history record and similar incident review of the reported lot could not be conducted because the part and lot number were not provided.The reported patient effect of death is listed in the supera peripheral stent system instructions for use (ifu) as a potential adverse event.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 events reported in the article are captured under a separate medwatch report number.Literature attachment: article title: endovascular therapy with interwoven nitinol stent placement after predilation for heavily calcified femoropopliteal artery disease: results of the burdock study.

Event Description

It was reported in a research article which evaluated 308 limbs which were implanted with a supera self expanding stent for calcified femoropopiteal lesions.The primary outcome measure was freedom from restenosis at 1 and 2 years and the secondary outcome measure was freedom from clinically driven target lesion revascularization.Clinical parameters with loss of patency were explored.There was death due to cardiovascular death, pneumonia and sepsis.Other adverse effects included transfusion-requiring bleeding, acute occlusion, distal emboli, major amputation, target lesion revascularization, and dissection.Stent elongation was documented as 3.5%.It was found that supera stents demonstrate clinically acceptable patency after sufficient pre-dilatation.Additional details can be found in the attached article "endovascular therapy with interwoven nitinol stent placement after predilation for heavily calcified femoropopliteal artery disease: results of the burdock study".

• 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: 18278483
• MDR Text Key: 329873413
• Report Number: 2024168-2023-13543
• 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: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• 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 Sex: Male