MAUDE Adverse Event Report: NOVUS SCIENTIFIC AB TIGR MATRIX; SURGICAL MESH

Model Number	NSTM1520
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Seroma (2069)
Date of Event	01/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Global medical partners is the initial importer of the tigr matrix surgical mesh (manufactured by novus scientific ab (sweden).On 01-aug-2024, global medical partners, llc first became aware of a medwatch report (mw5157343) submitted by a patient, who suffered from complications after a breast lift surgery, where the tigr matrix surgical mesh was used.The patient indicated that she had developed a seroma in both breasts, and that the incision separated in multiple areas, with pieces of mesh protruding out of each open area.Patient also indicated that this has caused a lengthy recovery with extended follow up care, and that a scar revision surgery would be necessary in the future.On 06-aug-2024, after obtaining additional information from the surgeon, dr.(b)(6) ((b)(6) plastic surgery), global medical partners, llc informed the manufacturer - novus scientific ab (uppsalla, sweden) of this medwatch report, provided the additional details from the surgeon, and requested the manufacturer to inform global medical partners if the decision would be made to submit a medical device report to fda.Dr.(b)(6) provided the following timeline of events: (b)(6) 2023 - surgery.(b)(6) 2023 - post-op appointment - no major events reported.(b)(6) 2024 - patient called with a right breast seroma.(b)(6) 2024 - dehiscence first noted.(b)(6) 2024 - no evidence of infection.(b)(6) 2024 - follow-up: completed antibiotics.No drains were placed.(b)(6) 2024 - patient placed on two antibiotics.(b)(6) 2024 - patient still had drainage from the right breast.(b)(6) 2024 - exposed mesh was cut out locally in the office.(b)(6) 2024 - cellulitis resolved, drainage is minimal.Left breast almost completely healed.There was still a wound on the right breast with local wound care.(b)(6) 2024 - small area still open with exposed mesh (0.5 x -0.5 cm).Additional notes from surgeon: - seroma was never drained/aspirated; - patient was never taken back to the or for reoperation; - no drains were used during surgey.On 28-aug-2024, global medical partners obtained further information from the surgeon, stating that seroma and wound dehiscence are a common potential issue with this type of surgery and that he did not believe that the tigr matrix was to blame for the issue, as he has experienced the same issues with other similar devices.On 30-aug-2024, novus scientific ab confirmed to global medical partners that they would not be submitting an emdr to fda, based on their own investigation, and also based on dr.Dalagiannis exper opinion that the tigr matrix was unlikely to be the cause of the issues.On 11-sep-2024, global medical partners became aware of a second medwatch report (mw5157343-1) for the same issue, also submitted by the patient, which provided current pictures as additional information to the previous report.The manufacturer was informed of the new medwatch report on 12-sep-2024.On 12-sep-2024, global medical partners decided, out of an abundance of caution, to submit this report to fda, despite the novus internal investigation findings which concluded that it is unlikely that the incident was caused by the novus scientific ab tigr matrix.

• Brand Name: TIGR MATRIX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): NOVUS SCIENTIFIC AB; virdings alle 2; uppsala, 754 5 0; SW 754 50
• MDR Report Key: 20292709
• Report Number: 3003895717-2024-00001
• Device Sequence Number: 8127454
• Product Code: FTL
• UDI-Device Identifier: 07332999000239
• UDI-Public: (01)07332999000239(10)167100-01260911230911
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2024
• Report Date (Section F): 08/06/2024

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 Expiration Date: 09/11/2026
• Device Model Number: NSTM1520
• Device Lot Number: 167100-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/01/2024
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 08/06/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White