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); Obstruction/Occlusion (2422); Vascular Dissection (3160); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 01/01/2016

Event Type  Injury  

Event Description

It was reported through the post market clinical follow up (pmcf) report, that the supera stent may be related to the adverse patient effects of thrombosis, embolization, dissection, perforation, occlusion, re-stenosis, revascularization, unplanned amputation / surgical intervention, and the device malfunction of failure to cross.Details are listed in the attached article, titled post-market clinical follow-up evaluation report peripheral self-expanding stents please see the attached post market clinical follow up evaluation report for specific information.

Manufacturer Narrative

Date of event ¿ estimated.The unique device identifier (udi) is unknown because the part number and lot number were not provided.Date of implant ¿ estimated.The device was not returned for analysis.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 was not provided.The reported patient effects of embolism, stenosis, thrombosis, occlusion, dissection, and perforation are listed in the supera peripheral stent system instructions for use as a potential adverse event.A conclusive cause for the reported thrombosis/thrombus, embolism/embolus, vascular dissection, perforation of vessels, obstruction/occlusion, and stenosis and the relationship to the product, if any, cannot be determined.The treatments 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 patient effect of death and other patient effects reported in the pmcf are captured under separate medwatch reports.Literature attachment: article title "rpt2131801, post market clinical follow-up evaluation report peripheral self-expanding stents".

• 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: 15170549
• MDR Text Key: 297309602
• Report Number: 2024168-2022-08576
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SUPERA
• Device Lot Number: UNKNOWN SUPERA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2022
• 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): Disability; Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male