MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 16 X 20, FIRM; MESH, SURGICAL

Catalog Number	1620002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fungal Infection (2419)
Date of Event	05/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the internal investigation into lot sp200379 with no remarkable findings, including 160 devices distributed with no other complaints reported against the lot and no deviations or nonconformances revealed during manufacturing, strattice as a contributing factor to the event cannot be ruled out, thus this event was reported to the fda as serious injury.Lot sp200379 was terminally sterilized and met all qc release criteria.It was reported the infection disease physician indicates a relationship between the strattice and the infection.As indicated in the instructions for use, infection is a potential adverse event associated with implantation procedures where surgical mesh materials are use.No further actions are required, no device nonconformances were confirmed.
Event or Problem Description
On september 7th, 2022, abbvie pmqa received notification through the fda originated letters system of medsun mandatory and voluntary medwatch report form (b)(4).The report was submitted by the specialist risk management and safety person at the reported facility.The report states "65 year old male patient who weighed 83 kg underwent liver transplant.Patient returned to or a few days later for abdominal wall closure with strattice mesh.This is one of two cases where there was possible strattice mesh contamination which resulted in post-operative infections of immunocompromised transplant patients.Or cultures grew a multidrug resistant organisms (mdro) and fungus.The original intended procedure was listed as liver transplant.Relevant history was reported to have included preexisting characteristics that may have contributed to the event: immuno-compromised.The device lot associated with this event is sp200379-029 with date of event as (b)(6) 2022.The device is not available for evaluation.On 9/14/22, pmqa received additional information from the medical professional that the patient underwent a transplant bring back liver; fascial closure with bridging of stratice on (b)(6) 2022.The patient experienced significant liver transplant postoperative complications including hemorrhagic shock, biliary leak requiring multiple washouts with intra-abdominal sepsis.On (b)(6) 2022, the abdominal strattice mesh with visible fungal growth with 24 x 5.5 cm fluid collection below mesh s/p exploratory laparotomy with abdominal washout, mesh excision, and primary closure of fascia on (b)(6) 2022.Culture with vre faecalis, ampicillin-susceptible; daptomycin-intermediate, and filamentous fungus.The patient co-morbidities include diabetes mellitus.The patient is still in the hospital; critically ill.It was reported the infectious disease physician indicates a relationship between the strattice and the infection.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 16 X 20, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 15529037
• Report Number: 1000306051-2022-00161
• Device Sequence Number: 2506804
• Product Code: FTM
• UDI-Device Identifier: 00818410010010
• UDI-Public: 00818410010010
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2022

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: 1620002
• Device Lot Number: SP200379
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 10/03/2022
• 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: 65 YR
• Patient Sex: Male