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

Model Number UNKNOWN PARIETENE MESH PRODUCT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Seroma (2069); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559)

Event Date 07/06/2021

Event Type  Injury  

Event Description

According to the literature source of study performed between january 2015 and february 2021, which was a retrospective study analyzed outcomes of patients who underwent redo-transversus abdominis release for ventral hernia repair with mesh, there were 65 patients in the study and a composite mesh was used in 5 patients, a monofilament mesh was used in 1 patient and a flat multifilament mesh was used in 1 patient.It was not specified if complications occurred in patients who received the mesh products.It was noted that postoperative complications included: infection, seroma, contaminated mesh and bowel obstruction.Treatment included: antibiotics, wound debridement, percutaneous drainage and reoperations.Two patients underwent reoperation for deep infection with mesh removal and wound dehiscence with mesh exposure.Readmission was required for bowel obstruction and wound complications.Hospital stay was extended with a median of 6 days.Article: k.C.Montelione, 2021, hernia (2021) 25:1581¿1592; https://doi.Org/10.1007/s10029-021-02457-x; springer-verlag france sas, part of springer nature 2021.

Manufacturer Narrative

Title: outcomes of redo-transversus abdominis release for abdominal wall reconstruction source: hernia (2021) 25:1581¿1592 accepted: 6 july 2021.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.The evaluation found no potentially contributing factors.It was reported that the patient had experienced a medical complication as a result of device usage and an extended inpatient stay was required from product failure.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 14288753
• MDR Text Key: 290811222
• Report Number: 9615742-2022-00429
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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; Hospitalization
• Patient Age: 60 YR