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

Model Number	ARTY
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, weight, bmi at the time of index procedure the diagnosis and indication for the initial surgical procedure? other relevant patient history/concomitant medications.Any concurrent procedure/device implantation? on what tissue was the suture used? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? how was the suture placed, interrupted or continuous? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? product lot # of the suture.Describe any medical/surgical intervention for exposure including dates and surgical findings.What is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? event related to vicryl suture reported via mw # 2210968-2021-11136.
Event or Problem Description
It was reported that a patient underwent a laparoscopic apical colpopexy on (b)(6) 2020 and the mesh was implanted.It was reported that during surgery the doctor observed fibrosis around bladder transition toward vagina.It was reported that during tissue dissection, the doctor made a 2cm large hole in the vagina and used suture in two layers for closing the hole.It was also reported that the doctor could not loosen the bladder without a high risk of bladder lesion, but the operation was proceeded as uncomplicated.It was reported that the patient had a three-moth check up visit on an unknown date in (b)(6) 2021, and the patient still had prolapsed genes.It was reported that upon gynecological examination, the doctor saw a 5x5mm mesh erosion in the vaginal top/womb and cut and removed a few millimeters of mesh erosion.It was also reported that a transvaginal ultrasound scan found the mesh was smooth around the vagina tube.Additional information was requested.

• 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 D2284 1; GM D22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12781119
• Report Number: 2210968-2021-11135
• Device Sequence Number: 11689566
• Product Code: OTO
• UDI-Device Identifier: 10705031218475
• UDI-Public: 10705031218475
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2021

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 Model Number: ARTY
• 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: 10/10/2021
• Initial Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female