MAUDE Adverse Event Report: ETHICON INC. ARTISYN Y-SHAPED MESH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number	ARTY
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	04/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The following information was requested, but unavailable: please provide the patient's demographic information including weight, bmi at the time of index procedure.Were any concomitant procedures performed? what was the initial approach for the index surgical procedure? were there any intra-operative complications? other relevant patient history/concomitant medications? please provide the mesh exposure site/location, symptoms and diagnostic confirmation.Were any deficiencies or anomalies noted with mesh device? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? please describe any medical intervention performed including medication name and results.What is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? to date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a da vinci sacrocolpopexy procedure on (b)(6) 2020 and mesh was implanted.On (b)(6) 2021, at 3 months, there was control, but 0.5 x 0.5 cm mesh erosion in vag top and a few millimeters of mesh was cut off.On (b)(6) 2022, at the 1-year follow-up, there were no prolapse annoyances, but unchanged mesh exposure, which was cut a little.On (b)(6) 2023, at the 2-year check, there was unchanged mesh exposure.On (b)(6) 2024, at the 3-year check, prolapse when toilet visit was noted and anterior wall plastic surgery was planned.On (b)(6) 2024, the patient underwent anterior colporaphy and removal of foreign bodies in the vagina.The mesh was exposed and removed.On (b)(6) 2024, finding of actiomyces in synthetic mesh.No further information is available.

• Brand Name: ARTISYN Y-SHAPED MESH
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt ; GM
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19939727
• Report Number: 2210968-2024-08209
• Device Sequence Number: 14684697
• Product Code: OTO
• UDI-Device Identifier: 10705031218475
• UDI-Public: (01)10705031218475(11)191015(17)210930(10)PLBCPXC0
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K113205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 09/30/2021
• Device Catalogue Number: ARTY
• Device Lot Number: PLBCPXC0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2019
• 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: Female