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

Catalog Number 2030002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Seroma (2069); Hernia (2240)

Event Date 08/27/2020

Event Type  Injury  

Event 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.

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.

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 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
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 14435248
• MDR Text Key: 292048867
• Report Number: 1000306051-2022-00091
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00818410010393
• UDI-Public: 00818410010393
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150712
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2030002
• Device Lot Number: SP100605
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NO INFORMATION REPORTED; NO INFORMATION REPORTED
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male