MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST MESH; SURGICAL MESH

Catalog Number 5954450

Device Problem Material Separation (1562)

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

Event Date 01/10/2023

Event Type  malfunction  

Event Description

As reported, during a robotic assisted laparoscopic ventral hernia repair, the ventralight st mesh was dipped in saline, rolled, inserted into the trocar and when unrolled, the mesh was sticking to itself; would not unroll easily.It was reported that the surgeon removed the mesh from the patient and noted the sepra coating had peeled off from the mesh.As reported, another mesh was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

Evaluation of the returned sample finds the st coating to have separated from an area on the mesh, which resulted in a void of the hydrogel barrier.The separation of the hydrogel coating is likely the result of over or under hydration of the device and/or handling of the device during deployment.No manufacturing anomalies were found.The size of the trocar and hydration time were not reported.Root cause is inadvertent damage during user device interface.Review of manufacturing records confirm product was manufactured to specification.(b)(4).Per the instructions-for-use (ifu), the ¿ventralight st mesh should be hydrated for no more than 1-3 seconds just prior to laparoscopic placement.If sutures are being placed, attach the sutures to the ventralight st mesh before hydration.The mesh must be rolled immediately after hydration about its long axis (lengthwise) with the bioresorbable coating inside to protect the bioresorbable coating.A minimum sized trocar is recommended for the laparoscopic delivery of ventralight st mesh.Insert the mesh through the trocar using a rigid instrument, such as non-serrated, 5 mm forceps; do not over force the mesh through trocar.If ventralight st mesh is hydrated longer than 3 seconds and/or does not easily deploy down the trocar, replace trocar and retry with the next available larger sized trocar.Note, the trocar size used in this procedure was not provided, the minimum trocar size per the ifu for product code used (5954450) is 10mm.

• Brand Name: VENTRALIGHT ST MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 16337940
• MDR Text Key: 309400593
• Report Number: 1213643-2023-00039
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2024
• Device Catalogue Number: 5954450
• Device Lot Number: HUGT1992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2022
• 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): Other
• Patient Age: 66 YR
• Patient Sex: Male