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

Catalog Number 2020002

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 07/08/2020

Event Type  Injury  

Manufacturer Narrative

The internal investigation is pending and will be reported in a follow up report along with the investigation conclusion.

Event Description

It was reported through a legal event that a 48 year female patient had hernia repair surgery on or about (b)(6) 2010.During the hernia repair surgery, the surgeon implanted a strattice, 2020002- (b)(4).After surgery, 10 years later, the patient returned to the hospital on or about (b)(6) 2020 and was diagnosed with a huge symptomatic recurrent incisional hernia.The patient underwent a diagnostic laparoscopy, lysis of adhesions and open incisional hernia repair with placement of additional mesh.The strattice mesh was found to have disintegrated.

Manufacturer Narrative

Internal investigation into strattice lot s10613 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 06/23/2022, of the 232 devices released to finished goods for lot s10613, 218 have been distributed with 132 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.No further actions are required as a nonconformance could not be confirmed.

Event Description

This is follow up#1 to report the results of the investigation including the conclusion.As reported in the initial: it was reported through a legal event that a 48 year old female patient had hernia repair surgery on or about (b)(6) 2010.During the hernia repair surgery, the surgeon implanted a strattice, 2020002- (b)(6).After surgery, 10 years later, the patient returned to the hospital on or about (b)(6) 2020 and was diagnosed with a huge symptomatic recurrent incisional hernia.The patient underwent a diagnostic laparoscopy, lysis of adhesions and open incisional hernia repair with placement of additional mesh.The strattice mesh was found to have disintegrated.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 14713533
• MDR Text Key: 295028536
• Report Number: 1000306051-2022-00109
• 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: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2020002
• Device Lot Number: S10613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2022
• 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: 48 YR
• Patient Sex: Female