MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH; MESH, SURGICAL, POLYMERIC

Model Number PCO6VP

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during an open mesh repair ventral hernia, while inserting the mesh, the expander broke.A new mesh was used to complete the case.There was no patient injury.

Manufacturer Narrative

Evaluation summary: one device was returned for investigation.A review of the device history record has been performed and no failure that may relate to the reported conditions have been noted.Especially, the records related to the records related to the molding of the ring and the handles positioning were found within qa specifications.The visual examination of the returned sample shows that:the sample was returned in its original packaging (commercial box, aluminum pouch, tray petg and tyvek lid).The sample was found contaminated by blood and dry.The mesh dimension, sewing and the removable handles were found as expected.The collagen film was partially delaminated from the mesh, mainly around the mesh.The expander placed on the side of the blue handle was found broken.The folding of the mesh goes in the direction of this break.The reported condition was confirmed.The mesh was broken in one side of the pgla expanders, not in the normal location for folding the mesh.The product ifu which accompanies each device states in chapter ¿operating steps ¿ positioning¿ that ¿fold the hydrated parietex¿ composite ventral patch in half along the junction of the two violet expanders.¿ it should be noted that the size of the defect is 4 cm and the product ifu which accompanies each device states in chapter - warning and precautions ¿ (¿) 3.The mesh must be implanted with a sufficient overlap on all sides of the defect¿.Based on our investigation and a complaint history review, the manufacture of the device is not suspected.There is no indication that there is a defective lot or that this event represents an emerging adverse quality trend.The product was not returned to us for evaluation; therefore, we are unable to identify the specific cause for the problem reported.The file will be closed as unconfirmed at this time.If additional information is obtained, or the sample is returned, we will re-open this investigation.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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: MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 8300584
• MDR Text Key: 134859954
• Report Number: 9615742-2019-00212
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521514157
• UDI-Public: 10884521514157
• Combination Product (y/n): N
• PMA/PMN Number: K120506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: PCO6VP
• Device Catalogue Number: PCO6VP
• Device Lot Number: POG0095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Date Manufacturer Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1