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

Catalog Number	ARTY
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Micturition Urgency (1871); Pain (1994); Prolapse (2475); Unspecified Kidney or Urinary Problem (4503); Insufficient Information (4580)
Date of Event	05/24/2023
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.An attempt has been 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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.H6 component code: g07002 ¿ device not returned.H6 clinical code: e2402 ¿ postoperative abnormal defecation.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: international urogynecology journal (2023) 34:2501¿2506.Https://doi.Org/10.1007/s00192-023-05552-y.
Event or Problem Description
Title: midterm comparison of laparoscopic high uterosacral ligament suspension and sacrocolpopexy in the treatment of moderate to severe apical prolapse.The objective was to retrospectively analyze the midterm efficacy of laparoscopic high uterosacral ligament suspension (hus) and sacrocolpopexy (sc) in the treatment of moderate to severe apical prolapse.Patients with pelvic organ prolapse (pop) who underwent laparoscopic hus (group a, n=72) and those who underwent lsc (mesh added, group b, n=54) between 1 january 2013 and 31 december 2019 were included in the study.Their mean age was 57.11±9.14 years and 56.93±7.52 years, respectively.In the hus group, the sacral ligaments on both sides are sutured to the vaginal stump or the posterior wall of the cervix using pds ii polydioxanone monofilament synthetic absorbable suture and knotted.In the lsc group, a y-shaped piece of mesh (arty,eth201 v002, johnson&johnson international, norderstedt, germany) is cut out and placed in the abdominal cavity.The median postoperative follow-up duration was 48 months (range 24¿84).Reported complications in group a include recurrent vaginal anterior wall prolapse (n=4), abnormal urination (n=5.56%), and postoperative abnormal defecation (n=1.39%).In group b include relapsed (n=1), intermittent pain (n=2), mesh exposure (n=2), abnormal urination (n=5.41%), and postoperative abnormal defecation (n=9.26%).In conclusion, the midterm curative effect of laparoscopic hus is similar to that of sc in the treatment of moderate to severe apical prolapse.The former has the advantages of less intraoperative blood loss, shorter postoperative hospital stay, lower cost, fewer new defecation abnormalities, and there were no complications related to mesh.

• 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.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20334781
• Report Number: 2210968-2024-10396
• Device Sequence Number: 7836244
• Product Code: OTO
• UDI-Device Identifier: 10705031218475
• UDI-Public: 10705031218475
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,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 Catalogue Number: ARTY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 09/30/2024
• 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 Sex: Unknown