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 Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Conclusion: upon review of the article received, there is one death event listed in the randomization table for biological mesh at the end of the article but not in the results section or in complication data. We do not know if this death event is outside the study or if the patient completed the study. The device has not been returned to allergan for evaluation. Based on limited information, a relationship between the event and the strattice could not be determined. Due to lack of information, strattice as a contributing factor cannot be ruled out. Lifecell reports the event in abundance of caution. Multiple attempts to obtain additional information are being made; however to date, no further information has been obtained. Article citation: ¿preventing recurrence in clean and contaminated hernias (price): a randomized trial of biologic versus synthetic mesh in ventral hernia repair¿, hobart w. Harris, md, et. Al.

Event Description

During a literature review of a study manuscript titled ¿preventing recurrence in clean and contaminated hernias (price): a randomized trial of biologic versus synthetic mesh in ventral hernia repair¿ by hobart w. Harris, md, et. Al. , was identified which reported hernia repairs for 163 patients operated on by one of eight surgeons participating in the study. Of these patients , 81 were implanted with strattice. Following implantation surgery for hernia repair, one death was documented, the cause of which was not stated. As it is unknown which patients experienced which events, this record has been created to capture the event of death. The affected location was not specified for the patients; therefore, the location will be captured as unknown. The overall conclusion reported that use of biologic mesh rather than synthetic mesh to repair potentially contaminated or contaminated ventral hernias increases the risk of hernia recurrence without a reduction in postoperative complications.

• 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 ; 9089471100
• MDR Report Key: 8239484
• MDR Text Key: 132778954
• Report Number: 1000306051-2019-00004
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK 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 Received: 12/12/2018
• 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: 01/11/2019 Patient Sequence Number: 1