MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PROGRIP; MESH, SURGICAL, POLYMERIC

Model Number TEM3015G

Device Problems Difficult to Insert (1316); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2020

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 a robotic transabdominal retromuscular umbilical prosthetic hernia repair, the insertion of the mesh through the trocar was difficult.When manipulating the mesh to put on place, the surgeon noticed a tear almost at the middle of the mesh.To avoid mesh failure, the surgeon removed the mesh from the abdomen.Another device was used to complete the case.There was no patient injury.

Manufacturer Narrative

H3 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 mechanical testing of the textile batch (ttd1523, cqr392485 and ttd1524, cqr392486) were found within qa specifications.The visual examination of the returned sample shows that: the sample was returned in its original commercial box, ifu and tyvek lid.The sample was placed in a plastic bag.The sample was found folded in 4, grip side and contaminated by blood.The textile knitting pattern was found as expected.The mesh was found cut (around 23 cm x 14 cm).Initial mesh dimension is 30 cm x 15 cm.2 blue lines were drawn on the mesh (one vertical, the other horizontal, forming 4 rectangles of similar sizes).The mesh was torn at one edge of the mesh.On the same side, the mesh was frayed on the edge.On the horizontal line, at 9,5 cm from the left edge a hole was found.Its dimensions were 1 cm x 0,3 cm.The reported condition was confirmed.It should be noted that the mesh was placed with robotic assistance and that ¿the insertion of the mesh through the trocar was difficult¿.It was specified that the trocar used was a ¿robot trocar¿ with no further information on its size.As the mesh was returned folded in 4, grips inside, we cannot determine how the mesh was folded while passing by the trocar.The product ifu which accompanies each device states in chapter ¿warnings and precautions¿ that ¿- excessive tension should be avoided on the progrip¿ self-gripping polyester mesh and suture attachment points to account for wound shrinkage during the healing process¿.Based on the available information, 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 reported condition was confirmed.An excessive tension through the trocar is highly suspected.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: PROGRIP
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 9722770
• MDR Text Key: 191409728
• Report Number: 9615742-2020-00377
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521177741
• UDI-Public: 10884521177741
• Combination Product (y/n): N
• PMA/PMN Number: K081050
• 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: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TEM3015G
• Device Catalogue Number: TEM3015G
• Device Lot Number: STE2376X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Date Manufacturer Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1