MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM; MESH, SURGICAL

Catalog Number 2030002

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

Patient Problem Hernia (2240)

Event Date 12/17/2014

Event Type  Injury  

Manufacturer Narrative

This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.The lot associated with this event was not reported and remains unknown; therefore a review of the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information reported, a relationship between the event and strattice cannot be confirmed.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 (b)(6) year old male patient had hernia repair surgery on or about (b)(6) 2014.During the repair surgery, the surgeon implanted a strattice mesh.After surgery, the patient returned to the hospital for a revision surgery on (b)(6) 2014, where the existing strattice mesh was explanted and a new strattice reconstructive tissue mesh was implanted.

Event Description

This is follow up#1 to report on (b)(6) 2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is sp100126-007 and s11241-015.No other information was provided.This record is associated with sp100126-007 ((b)(6) 2014 implant).As reported in the initial: it was reported through a legal event that a 66 year old male patient had hernia repair surgery on or about (b)(6), 2014.During the repair surgery, the surgeon implanted a strattice mesh.After surgery, the patient returned to the hospital for a revision surgery on (b)(6), 2014, where the existing strattice mesh was explanted and a new strattice reconstructive tissue mesh was implanted.

Manufacturer Narrative

This is follow up#1 to report that on (b)(6) 2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is sp100126-007.No other information was provided.The internal investigation is pending and will be reported in a follow up report along with the investigation conclusion.As reported in the initial: this legal event is being reported as serious injury due to the reported recurrence with surgical intervention.The lot associated with this event was not reported and remains unknown; therefore a review of the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information reported, a relationship between the event and strattice cannot be confirmed.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.

Manufacturer Narrative

This follow up is to report the results from the internal investigation and conclusion.Internal investigation into strattice lot sp100126 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 09/oct/2022, of the (b)(4) devices released to finished goods for lot sp100126, 195 have been distributed with 149 reported as implanted.Based on our internal investigation 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.As reported in follow up #1: this is follow up#1 to report that on 14/sept/2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is sp100126-007.No other information was provided.The internal investigation is pending and will be reported in a follow up report along with the investigation conclusion.As reported in the initial: this legal event is being reported as serious injury due to the reported recurrence with surgical intervention.The lot associated with this event was not reported and remains unknown; therefore a review of the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information reported, a relationship between the event and strattice cannot be confirmed.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.

Event Description

This is follow up#2 to report the results from the internal investigation and the conclusion.The aware date of october 9, 2022 is based on when the batch record review was completed.As reported in follow up#1: this is follow up#1 to report on 14/sept/2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is sp100126-007 and s11241-015.No other information was provided.This record is associated with sp100126-007 ((b)(6) 2014 implant).As reported in the initial: it was reported through a legal event that a 66 year old male patient had hernia repair surgery on or about (b)(6) 2014.During the repair surgery, the surgeon implanted a strattice mesh.After surgery, the patient returned to the hospital for a revision surgery on (b)(6) 2014, where the existing strattice mesh was explanted and a new strattice reconstructive tissue mesh was implanted.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 13843903
• MDR Text Key: 287580782
• Report Number: 1000306051-2022-00034
• 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,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2030002
• Device Lot Number: SP100126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2022
• 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 REPORTED
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male