MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 40, FIRM; MESH, SURGICAL

Catalog Number 2040002

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

Patient Problems Hernia (2240); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/16/2017

Event Type  Injury  

Manufacturer Narrative

Internal investigation into strattice lot sp100235 included a review of the reported information, review of the device history records, and a review of the complaint history records.The investigation resulted in no remarkable findings, including no other complaints reported against the lot and no deviations or related non-conformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.As of 06/30/2022, of the 184 devices released to finished goods for lot sp100235, 175 have been distributed with 126 reported as implanted.Based on our internal review with no remarkable findings, and without relevant patient factors, a relationship between the strattice and this event could not be determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.

Event Description

It was reported through a legal event that a 68 year old patient had hernia repair surgery on or about (b)(6) 2015.During the hernia repair surgery, the surgeon implanted a strattice mesh; model/catalog number is 2040002 and the lot number is sp100235-204.After surgery, the patient returned to the hospital on or about (b)(6) 2017 and was diagnosed with a recurrent incisional hernia and underwent a repair of an abdominal wall hernia and lysis of adhesions.The biologic mesh was noted to have degraded and reabsorbed, and there were multiple loops of bowel within the recurrent hernia.The hernia was repaired with the placement of additional mesh.On or about (b)(6) 2018, the presented with pain, swelling, and drainage at the site of the ventral hernia repair from august 2017 and underwent an incision and debridement for abdominal abscess and had a wound vac placed.This record is associated with sp100235-204, record 1 of 2.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 40, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 14989995
• MDR Text Key: 295727236
• Report Number: 1000306051-2022-00117
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00818410010409
• UDI-Public: 00818410010409
• 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: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 2040002
• Device Lot Number: SP100235
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2022
• 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
• Treatment: NO INFORMATION
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR