MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM; MESH, SURGICAL

Catalog Number	1010002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	06/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal investigation into strattice lot sp200172 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 (b)(6) 2022, of the 136 devices released to finished goods for lot sp200019, 132 have been distributed with 78 reported as implanted.Based on our internal review with no remarkable findings, 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 or Problem Description
It was reported through a legal event that a (b)(6) female patient underwent open repair of ventral/incisional hernia repair surgery on or about (b)(6) 2020.During the hernia repair surgery, the surgeon implanted a strattice firm mesh, item 1010002, lot sp200172 in her.After surgery, the patient returned to the hospital on or about (b)(6) 2021 and was diagnosed with a recurrent ventral hernia.On or about (b)(6) 2021, she underwent open repair of recurrent ventral/incisional hernia with mesh and left and right myocutaneous muscle release for component separation.
Event or Problem Description
This is follow up#2 to report pmqa was made aware 7/8/22 that the dhr investigation was performed on the wrong lot inadvertently and this follow up is to report the investigation conclusion on the correct lot.As reported in follow up#1: this is follow up# 1 to report on june 16, 2022, pmqa received an email from legal that indicated the sublot number associated with this event is -075.The serial number has been updated to (b)(6).As reported in the initial: it was reported through a legal event that a 49 year old female patient underwent open repair of ventral/incisional hernia repair surgery on or about (b)(6) 2020.During the hernia repair surgery, the surgeon implanted a strattice firm mesh, item 1010002, lot sp200172 in her.After surgery, the patient returned to the hospital on or about june 3, 2021 and was diagnosed with a recurrent ventral hernia.On or about (b)(6) 2021, she underwent open repair of recurrent ventral/incisional hernia with mesh and left and right myocutaneous muscle release for component separation.
Additional Manufacturer Narrative
Internal investigation into strattice lot sp200172 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 4/28/22, of the (b)(6) devices released to finished goods for lot sp200172, (b)(6) have been distributed with (b)(6) reported as implanted.Lot sp200172 was processed aseptically, terminally sterilized and met all qc release criteria.Based on our internal review with no remarkable findings, a relationship between the strattice and this event could not be determined.No further actions are required as a nonconformance could not be confirmed.
Additional Manufacturer Narrative
The individual piece that was implanted from lot sp200172 was identified as piece 075.The investigation conclusion that was reported in the initial medwatch that is associated with lot sp200172 remains the same.The investigation was performed on the entire lot and the piece number was included within the investigation.The relationship to the strattice remains undetermined.
Event or Problem Description
This is follow up# 1 to report on june 16, 2022, pmqa received an email from legal that indicated the sublot number associated with this event is -075.The serial number has been updated to (b)(6).As reported in the initial: it was reported through a legal event that a 49 year old female patient underwent open repair of ventral/incisional hernia repair surgery on or about (b)(6) 2020.During the hernia repair surgery, the surgeon implanted a strattice firm mesh, item 1010002, lot sp200172 in her.After surgery, the patient returned to the hospital on or about june 3, 2021 and was diagnosed with a recurrent ventral hernia.On or about (b)(6), 2021, she underwent open repair of recurrent ventral/incisional hernia with mesh and left and right myocutaneous muscle release for component separation.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 14437850
• Report Number: 1000306051-2022-00094
• Device Sequence Number: 20114840
• Product Code: FTM
• UDI-Device Identifier: 00818410010096
• UDI-Public: 00818410010096
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 1010002
• Device Lot Number: SP200172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 06/16/2022; 07/08/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 07/06/2022; 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO INFORMATION REPORTED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female