MAUDE Adverse Event Report: BRANCHBURG 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 Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	04/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Limited information was reported through a legal event that a patient was implanted with strattice on (b)(6) 2023.The form also indicates that on an unspecified date, the strattice implant had been ¿removed or revised¿.No information was provided on the indication for the initial surgery or the reason for the removal or revision.
Additional Manufacturer Narrative
The lot associated with this event was not reported and remains unknown; therefore a review into the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information, and without relevant patient factors, a relationship between the event and the strattice 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 (b)(6) 2024, pmqa received notification from legal that the plaintiff profile form was received associated with this event.As per the ppf form, the patient underwent a ventral hernia surgery and was implanted with strattice device lot unknown and ref# (b)(4) on (b)(6) 2023.On (b)(6) 2024, patient underwent explant mesh with enterolysis of adhesions & implant additional mesh (non-abbive device) underlay and onlay for recurrent ventral hernia repair with jp drain x 3 placement.As per the ppf form, the patient claims: interventional revision and removal surgeries, hernia recurrence, pain, mesh explant, mesh revision, additional mesh implant, jp drain x 3 placement the form lists the condition that was treated: interventional revision and removal surgeries, hernia recurrence, pain, mesh explant, mesh revision, additional mesh implant, jp drain x 3 placement between (b)(6) 2023 - (b)(6) 2024.The ppf form also indicates that the patient was implanted with a non-abbvie device, bard ventralight st; lot #: unknown; ref #: (b)(4) on (b)(6)2023.Patient was implanted with another non-abbvie device, bard ventralight st; lot #: unknown; ref #: (b)(4) on (b)(6)2024 by.The form indicates that the device was removed/revised on (b)(6)2024 due to ¿revision prior mesh with implant additional mesh underlay and onlay for recurrent ventral hernia repair with jp drain x 3 placement." as reported in the initial: limited information was reported through a legal event that a patient was implanted with strattice on (b)(6)2023.The form also indicates that on an unspecified date, the strattice implant had been ¿removed or revised¿.No information was provided on the indication for the initial surgery or the reason for the removal or revision.
Additional Manufacturer Narrative
This is a known potential adverse event addressed in the product labeling.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.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): BRANCHBURG; one millennium way; branchburg NJ 08876
• Manufacturer (Section G): BRANCHBURG; one millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 19868225
• Report Number: 1000306051-2024-00200
• Device Sequence Number: 7513596
• Product Code: FTM
• UDI-Device Identifier: 00818410010140
• UDI-Public: 00818410010140
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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 Catalogue Number: 2020002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 44 YR
• Patient Sex: Male