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 Seroma (2069); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/05/2022

Event Type  Injury  

Event Description

It was reported to abbvie that a strattice graft was explanted and replaced it with phasix.The case notes revealed that the surgeon noted the strattice graft was implanted during a prior ventral hernia; however, the graft failed to incorporate.The surgeon also noted, a small seroma formation and bowel adhesions to the mesh made, which made it difficult to move forward in the surgery, resulting in the meshes removal and replacement with a new piece of phasix mesh.No other information was reported.The lot number associated with this complaint its unknown.The graft will be returned for evaluation.Abbvie has made multiple attempts to attain additional information to aid this investigation, to date, no information has been reported.

Manufacturer Narrative

This event is being reported as serious injury due to the reported complications with surgical intervention.The lot associated with this event was not reported and remains unknown; therefore an internal investigation into the device history records could not be performed.The strattice device is pending return for evaluation.Based on the limited information, including no identification of the lot number, a relationship between the event and the strattice could not be determined.The nonincorporation was likely caused by the reported seroma, which can impact revascuralization.If additional information is received, a supplemental report will be submitted.

Manufacturer Narrative

Internal investigation of the unknown strattice graft was limited to analysis of the returned specimen.Pathology report c-1228 labeled for unknown strattice reported acellular graft material portions of ununiformly unincorporated collagen graft are seen.Stains for gridly fungal and b&b were performed.Multiple colonies of bacterial and budding yeast contaminant are seen at tissue edges and spaces.No reactive inflammatory tissue infiltrate is see.The lot number (s) remains unknown.If the lot number (s) becomes available, a follow-up report will be filed within 30 calendar days.This concludes our investigation.

Event Description

This follow-up #1 is being filed to report the results of the lab analysis performed on 09/01/2022.The lot (s) associated with this event remains unknown.

• 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: 15320393
• MDR Text Key: 298884410
• Report Number: 1000306051-2022-00142
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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