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 Problem Hernia (2240)

Event Date 12/12/2017

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

Limited information was reported through a legal event that a (b)(6) female patient underwent hernia repair surgery on or about (b)(6) 2011 and surgeon implanted a strattice hernia mesh into her as part of the surgery.After surgery, the patient returned to the hospital six years later on (b)(6) 2017 for a revision operation.

Manufacturer Narrative

This is follow up#1 to report that on august 11th, 2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is sp100153-052.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#1 to report on august 11th, 2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is sp100153-052.No other information was reported.As reported in the initial: limited information was reported through a legal event that a 52 year old female patient underwent hernia repair surgery on or about on (b)(6) 2011 and surgeon implanted a strattice hernia mesh into her as part of the surgery.After surgery, the patient returned to the hospital six years later on (b)(6) 2017 for a revision operation.

Manufacturer Narrative

This follow up is to report the results from the internal investigation and conclusion.Additional and/or corrected data.Internal investigation into strattice lot: sp100153 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 09/13/2022, of the (b)(4) devices released to finished goods for lot: sp100153, (b)(4) have been distributed with 119 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 august 11th, 2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is sp100153-052.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 september 13, 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 august 11th, 2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is sp100153-052.No other information was reported.As reported in the initial: limited information was reported through a legal event that a 53 year old male patient underwent a hernia repair surgery on or about on (b)(6) 2011 and the surgeon implanted a strattice firm mesh.After surgery, the patient returned to the hospital on or about on (b)(6) 2021, for a revision surgery.Limited information was reported through a legal event that a 52 year old female patient underwent hernia repair surgery on or about on (b)(6) 2011 and surgeon implanted a strattice hernia mesh into her as part of the surgery.After surgery, the patient returned to the hospital six years later on (b)(6) 2017 for a revision operation.

• 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: 13663296
• MDR Text Key: 289290733
• Report Number: 1000306051-2022-00026
• 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: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: SP100153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 03/03/2022
• Supplement Dates Manufacturer Received: 08/11/2022; 09/13/2022
• Supplement Dates FDA Received: 09/06/2022; 09/14/2022
• 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: 52 YR
• Patient Sex: Female