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

Model Number LPG1510

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2020

Event Type  malfunction  

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. Visual inspection noted that the product was used outside the instructions for use (ifu) specifications. It was reported that the mesh was difficult to adhere, did not stay in place, or shifted within the patient while being implanted. The reported issue was confirmed. The product analysis noted evidence that the device was not used as intended. 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. The instructions included with this device provide the following guidance: progrip¿ laparoscopic self-fixating mesh needs to be hydrated for a few seconds in a sterile saline solution before use. Rolling/folding of the mesh: a. For the rectangular mesh, it is recommended to roll the mesh in the length-wise direction. If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during robotic laparoscopic inguinal hernia repair, the mesh was not adhering/sticking as it should. A suture was used to keep it in place before closing the peritoneal space. There was no patient injury.

• Brand Name: PROGRIP
• 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: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 11189705
• MDR Text Key: 227489913
• Report Number: 9615742-2021-00160
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/18/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: LPG1510
• Device Catalogue Number: LPG1510
• Device Lot Number: PUF0774X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial