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

Catalog Number	2030002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Seroma (2069); Hernia (2240)
Date of Event	08/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through a legal event that a (b)(6) male patient underwent hernia repair surgery on or about (b)(6) 2019.During the patient¿s surgery, the surgeon implanted him with strattice lot sp100606 (sku 2030002).After surgery, the patient returned to the hospital on or about (b)(6) 2020, and was diagnosed with recurrent ventral incisional hernia, adhesions, chronic seroma, and small bowl lining deterioration due to mesh.On or about (b)(6) 2020, the patient underwent lysis of adhesions and hernia repair.During this revision surgery, the surgeon noted intra-abdominal adhesions involving the small bowel, omentum, transvest colon, anterior abdominal wall, and previously placed mesh.The surgeon also noted that the graft appeared folded on itself and bunched up along the fascial defect.Multiple loops of small bowel were noted to be decently adherent mesh with serosal erosion and a seroma anterior to the previously placed mesh.It should be the noted the lot number was provided without the serial number and the item number that correlates is 2030002p.
Additional Manufacturer Narrative
This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.Internal investigation into strattice lot sp100606 included a review of the reported information, review of the device history records, and a review of the complaint history records with no remarkable findings, including no other complaints reported against the lot and no deviations or non-conformances revealed during processing.The lot was aseptically processed, terminally sterilized within the process parameters, and met all qc release criteria.To date, of the (b)(4) devices released to finished goods, (b)(4) have been distributed with (b)(4) devices reported as implanted.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
Additional Manufacturer Narrative
This is a follow up #1 report to the internal investigation and conclusion.This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.Internal investigation into strattice lot sp100605 included a review of the reported information, review of the device history records, and a review of the complaint history records with no remarkable findings, including no other complaints reported against the lot and no deviations or non-conformances revealed with product impact.The lot was aseptically processed, terminally sterilized within the process parameters, and met all qc release criteria.To date, all 158 devices released to finished goods have been distributed with 86 devices reported as implanted.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 additional information reporting the lot number associated with this complaint.Lot sp100605-026.As reported in the initial: it was reported through a legal event that a 55-year-old male patient underwent hernia repair surgery on or about (b)(6) 2019.During the patient¿s surgery, the surgeon implanted him with strattice lot sp100606 (sku 2030002).After surgery, the patient returned to the hospital on or about (b)(6) 2020, and was diagnosed with recurrent ventral incisional hernia, adhesions, chronic seroma, and small bowl lining deterioration due to mesh.On or about (b)(6), 2020, the patient underwent lysis of adhesions and hernia repair.During this revision surgery, the surgeon noted intra-abdominal adhesions involving the small bowel, omentum, transvest colon, anterior abdominal wall, and previously placed mesh.The surgeon also noted that the graft appeared folded on itself and bunched up along the fascial defect.Multiple loops of small bowel were noted to be decently adherent mesh with serosal erosion and a seroma anterior to the previously placed mesh.It should be the noted the lot number was provided without the serial number and the item number that correlates is(b)(6).

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 14435248
• Report Number: 1000306051-2022-00091
• Device Sequence Number: 12202100
• Product Code: FTM
• UDI-Device Identifier: 00818410010393
• UDI-Public: 00818410010393
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K150712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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: 2030002
• Device Lot Number: SP100605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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; NO INFORMATION REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male