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

Catalog Number	2020002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	03/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Patient underwent primary incisional hernia repair.Strattice mesh implanted.Patient returned to the hospital 7 months later and was diagnosed with worsening symptomatic enlarging epigastric incisional hernia.Hernia mesh revision surgery completed.
Additional Manufacturer Narrative
Internal investigation into strattice lot sp100561 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 08/02/2022, of the 167 devices released to finished goods for lot sp100561, 163 have been distributed with 94 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.
Event or Problem Description
This is follow up # 1 to report on july 26th, 2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is sp100561-046.Additional information was also received that lot sp200027 was implanted during the (b)(6) 2019 revision surgery.There is no allegation or complaint reported against lot sp200027.This record is associated with sp100561.As reported in the initial: patient underwent primary incisional hernia repair.Strattice mesh implanted.Patient returned to the hospital 7 months later and was diagnosed with worsening symptomatic enlarging epigastric incisional hernia.Hernia mesh revision surgery completed.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ
• Manufacturer (Section G): LIFECELL; 1 millennium way; branchburg NJ
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 11614916
• Report Number: 1000306051-2021-00023
• Device Sequence Number: 3157458
• Product Code: FTM
• UDI-Device Identifier: 00818410010140
• UDI-Public: 00818410010140
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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: 2020002
• Device Lot Number: SP100561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 08/19/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female