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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL UNKNOWN STRATTICE MESH, SURGICAL

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LIFECELL UNKNOWN STRATTICE MESH, SURGICAL Back to Search Results
Catalog Number UNK STRATTICE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Fistula (1862)
Event Date 01/04/2020
Event Type  Injury  
Manufacturer Narrative
(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.
 
Event Description
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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Brand NameUNKNOWN STRATTICE
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
LIFECELL
1 millennium way
branchburg NJ 08876
Manufacturer (Section G)
LIFECELL
1 millennium way
branchburg NJ 08876
Manufacturer Contact
brent livingstone
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key10491309
MDR Text Key205704433
Report Number1000306051-2020-00046
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K070560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK STRATTICE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2020
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 Treatment Data
Date Received: 09/03/2020 Patient Sequence Number: 1
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