MAUDE Adverse Event Report: LIFECELL UNKNOWN STRATTICE; MESH, SURGICAL

Catalog Number UNK STRATTICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Article citation: jakob, m o, et al.Biologic mesh are associated with abdominal wall complications in patients undergoing emergency surgery ¿ results from a randomized-controlled clinical trial.Facility name: (b)(6) university hospital.This mdr is being reported as an individual event type for serious injury.Multiple attempts were made to contact the corresponding author for additional information, including relevant lot numbers.To date, no additional information has been obtained.The device was not returned for evaluation and the lot number remains unknown; therefore, internal investigation into the event could not be performed.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

Journal article "biologic mesh are associated with abdominal wall complications in patients undergoing emergency surgery ¿ results from a randomized-controlled clinical trial" discusses open, emergency abdominal surgery is associated with a high incidence of fascial dehiscence and incisional hernia.Biologic meshes potentially decrease such complications without mesh-associated complications.The aim of this prospective, randomized study was to compare the outcome after prophylactic, intraperitoneal implantation of biologic mesh with standard abdominal closure in emergency abdominal surgery.A randomized clinical trial was performed in patients undergoing emergency abdominal surgery at (b)(6) university hospital, (b)(6) from april 2016 to march 2019.Patients were randomly assigned to prophylactic implantation of a biological intraperitoneal mesh (strattice) or a single, continuous running suture.An emergent interim analysis had to be performed after the enrollment of 48 patients because of safety concerns.Consequently, patient enrollment had to be closed prematurely.Eligibility for inclusion was assessed in 61 patients.Of these, 48 patients (21 in the mesh group, 28 in the no-mesh group) were included in the study.No statistically significant differences in baseline characteristics were found between groups.Abdominal wall complications requiring revisional surgery were more frequent in the mesh group compared to the no mesh group (5 of 13 versus 1 of 13 patients, p=0.026).Mesh-associated abdominal wall complications included non-integration of the mesh into the abdominal wall, dissolution of the mesh, and mesh-related infections.Intraperitoneal biologic mesh implantation was associated with significantly more frequent high-grade abdominal wall complications in patients undergoing emergency abdominal surgery.Based on this result, the use of biologic meshes cannot be recommended in the contaminated environment of emergency abdominal surgery.

• Brand Name: UNKNOWN STRATTICE
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 10025061
• MDR Text Key: 192252192
• Report Number: 1000306051-2020-00018
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK STRATTICE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2020
• Initial Date FDA Received: 05/05/2020
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention