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

Catalog Number 5954450

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

The information provided regarding this event is limited, the contact reports being unable to provide any additional details.The sample was received manipulated for use as reported.The evaluation confirms for separation of the hydrogel barrier.The separation of the hydrogel observed is consistent with the hydrogel not being completely hydrated prior to rolling and insertion.The information provided is limited and it is unknown if the mesh was hydrated in preparation for the procedure.However, if only a portion of the mesh is hydrated and comes in contact with a dehydrated portion, the side that is hydrated is known to stick to the dry portion of the mesh.Based on the available information and product evaluation a definitive conclusion cannot be made.The instructions for use, supplied with the device state, 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 prosthesis 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 prosthesis through the trocar using a rigid instrument, such as non-serrated, 5 mm forceps; do not over force the prosthesis 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.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in may, 2017.

Event Description

It was reported that on (b)(6) 2017 during an unspecified hernia repair procedure while attempting to implant a bard ventralight st mesh, the surgeon noted that the hydrogel coating was pulling away from the mesh.The surgeon decided not to use the mesh and another bard ventralight st mesh was used to complete the case without issue.There was no injury to the patient.The surgeon is reported to be an experienced user of the bard ventralight st mesh.

• Brand Name: VENTRALIGHT ST MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6988731
• MDR Text Key: 91200894
• Report Number: 1213643-2017-00742
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031618
• UDI-Public: (01)00801741031618(17)190428(10)HUBS0287
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2019
• Device Catalogue Number: 5954450
• Device Lot Number: HUBS0287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2017
• 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 Age: 71 YR