MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN PARIETENE MESH PRODUCT; MESH, SURGICAL, POLYMERIC

Model Number UNKNOWN PARIETENE MESH PRODUCT

Device Problem Degraded (1153)

Patient Problems Erosion (1750); Prolapse (2475)

Event Date 05/17/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: unkabstack, unknown absorbatack.Title: comparison of laparoscopic lateral suspension and laparoscopic sacrocolpopexy with concurrent total laparoscopic hysterectomy for the treatment of pelvic organ prolapse: a randomized controlled clinical trial.Source: international urogynecology journal (2023) 34:231¿238, 10.1007/s00192-022-05267-6 received: 24 february 2022 / accepted: 17 may 2022.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

According to the literature source of study performed between january 2019 and january 2020, a retrospective study compared the outcomes of laparoscopic lateral suspension with total laparoscopic hysterectomy (lls-tlh) and laparoscopic sacrocolpopexy with total laparoscopic hysterectomy (lsc-tlh) in women with apical and anterior vaginal wall prolapse between january 2019 and january 2020.Parietene mesh was used in both procedures and secured to the vaginal wall with a competitor suture.There were 80 patients in the study with 40 in each group.Postoperative complications included: recurrence and mesh erosion.Mesh exposure occurred in one patient and required reoperation to excise the mesh.Three patients in the lls-tlh required reoperation for recurrence.

• Brand Name: UNKNOWN PARIETENE MESH PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 16417712
• MDR Text Key: 309976305
• Report Number: 9615742-2023-00255
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PARIETENE MESH PRODUCT
• Device Catalogue Number: UNKNOWN PARIETENE MESH PRODUCT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 02/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention