Catalog Number UNK ABSOLUTE PRO |
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 absolute pro.035 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 could not be conducted because the part and lot number was not provided.The reported patient effects of obstruction/occlusion and perforation leading to death are listed in the absolute pro.035 biliary self-expanding stent system instructions for use (ifu) as adverse events that may be associated with the use of a stent in the biliary tree.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 (pmcf) evaluation report peripheral self-expanding stents.".
|
|
Search Alerts/Recalls
|
|