MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 20, FIRM; MESH, SURGICAL

Catalog Number	1020002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	07/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This legal event is being reported as serious injury due to the reported recurrence with device explant.The internal investigation is pending and will be reported in a follow up report along with the investigation conclusion.
Event or Problem Description
It was reported through a legal event that a 69 year old man underwent a hernia repair surgery on or about (b)(6) 2014.During the hernia repair surgery, the surgeon implanted a strattice mesh in him.After surgery, the patient returned to the hospital on or about (b)(6) 2015 for a revision surgery.Subsequently, the patient returned to the hospital again on or about (b)(6) 2016 for a mesh explant surgery.On september 19, 2022, pmqa received notification from legal that the lots associated with this event were found through discovery and are (b)(4) ((b)(6) 2014 implant) and (b)(4) ((b)(6) 2015 implant).No other information was provided.The original summons did not report that a strattice device was implanted during the (b)(6) 2015 and therefore this record was originally cancelled.Since updated information was received that a second strattice device was implanted, this record was re-opened due to the report of device explant occurring after the second device was implanted and an investigation will be performed on (b)(4).The event code was updated to 'reherniation" in the assumption the revision surgery was to repair a recurrence.
Event or Problem Description
This is follow up#1 to report the results from the internal investigation and the conclusion.The aware date of november 2, 2022 is based on when the batch record review was completed.As reported in the initial: it was reported through a legal event that a 69 year old man underwent a hernia repair surgery on or about (b)(6), 2014.During the hernia repair surgery, the surgeon implanted a strattice mesh in him.After surgery, the patient returned to the hospital on or about (b)(6), 2015 for a revision surgery.Subsequently, the patient returned to the hospital again on or about (b)(6) 2016 for a mesh explant surgery.On september 19, 2022, pmqa received notification from legal that the lots associated with this event were found through discovery and are sp100102-167 ((b)(6) 2014 implant) and sp100253-246 ((b)(6) 2015 implant).No other information was provided.The original summons did not report that a strattice device was implanted during the (b)(6) 2015 and therefore this record was originally cancelled.Since updated information was received that a second strattice device was implanted, this record was re-opened due to the report of device explant occurring after the second device was implanted and an investigation will be performed on sp100253-246.The event code was updated to 'reherination" in the assumption the revision surgery was to repair a recurrence.
Additional Manufacturer Narrative
Internal investigation into strattice lot sp100253 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 11/02/2022, of the (b)(4) devices released to finished goods for lot sp100253, (b)(4) have been distributed with (b)(4) 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 the initial: this legal event is being reported as serious injury due to the reported recurrence with device explant.The internal investigation is pending and will be reported in a follow up report along with the investigation conclusion.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 20, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 15615941
• Report Number: 1000306051-2022-00181
• Device Sequence Number: 8007930
• Product Code: FTM
• UDI-Device Identifier: 00818410010379
• UDI-Public: 00818410010379
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2022

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 Catalogue Number: 1020002
• Device Lot Number: SP100253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 11/04/2022
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male