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Catalog Number UNK STRATTICE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Fistula (1862)
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Event Date 01/04/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6) medical center.Article citation: de vries, f.E.E., hodgkinson, j.D., claessen, j.J.M.Et al.Long-term outcomes after contaminated complex abdominal wall reconstruction.Hernia 24, 459¿468 (2020).This mdr is being submitted in an abundance of caution.Further follow up is being done with the authors to ascertain additional information.To date, no product information has been received, therefore no internal investigation can be performed.Device was not returned for analysis.Based on the reported information, a relationship between the event and strattice cannot be determined.If additional information is reported, a follow up adverse event report will be submitted.No further actions are required as a nonconformance could not be confirmed.
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Event Description
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In literature article "long-term outcomes after contaminated complex abdominal wall reconstruction", the following was reported: complex abdominal wall repair (cawr) in a contaminated operative field is a challenge.Available literature regarding long-term outcomes of cawr comprises studies that often have small numbers and heterogeneous patient populations.This study aims to assess long-term outcomes of modified-ventral hernia working group (vhwg) grade 3 repairs.Because the relevance of hernia recurrence (hr) as the primary outcome for this patient group is contentious, the need for further hernia surgery (fhs) was also assessed in relation to long-term survival.A retrospective cohort study with a single prospective follow-up time-point nested in a consecutive series of patients undergoing cawr in two european national intestinal failure centers.In long-term analysis, 266 modified vhwg grade 3 procedures were included.The overall hr rate was 32.3%.The hr rates for non-crosslinked biologic meshes and synthetic meshes when fascial closure was achieved were 20.3% and 30.6%, respectively.The rates of fhs were 7.2% and 16.7%, and occurred only within the first 3 years.Bridged repairs showed poorer results (fascial closure 22.9% hernia recurrence vs bridged 57.1% recurrence).Overall survival was relatively good with 80% en 70% of the patients still alive after 5 and 10 years, respectively.In total 86.6% of the patients remained free of fhs.In this study of contaminated cawr, non-crosslinked biologic mesh shows better results than synthetic mesh.Bridging repairs with no posterior and/or anterior fascial closure have a higher recurrence rate.The overall survival was good and the majority of patients remained free of additional hernia surgery.
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Search Alerts/Recalls
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