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

Catalog Number 5954450

Device Problems Material Separation (1562); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2018

Event Type  malfunction  

Manufacturer Narrative

As reported the surgeon did not hydrate the mesh prior to insertion.Per the instructions-for-use the mesh should be hydrated for no more than 1-3 seconds just prior to laparoscopic placement.The sample was returned in a contaminated state.The sample is noted to have a small section of hydrogel separated from the mesh, consistent with the hydrogel sticking and peeling away from the mesh.While attempting to place the non-hydrated device it is possible that fluid came in contact with areas of the hydrogel.Inherently, if a dry area of the hydrogel should come in contact with a hydrated area; the dry area will pull moisture from the hydrated area causing the two sides to stick together.An attempt to separate the two sides could result in the hydrogel peeling off of one side of the mesh and sticking to the other side.Based on the information provided and the sample evaluation this complaint is confirmed for use related.The ifu states, 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.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in december, 2017.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was report that on (b)(6) 2018 a robotic assisted laparoscopic incisional hernia repair was being performed with a bard/davol ventralight st mesh.As reported the mesh was inserted into the patient's abdomen without hydration.After insertion the mesh folded together and as the surgeon attempted to open it back up (within the abd), the sepra portion (hydrogel) of the mesh stuck together and peeled off of the polypropylene mesh.The surgeon reported removing the mesh from the patient's abdomen and used a bard/davol ventralight st w/ echo ps to complete the case without further issue.As reported, there was no patient injury or harm.

• 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: 7265995
• MDR Text Key: 100259823
• Report Number: 1213643-2018-00251
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031618
• UDI-Public: (01)00801741031618
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2019
• Device Catalogue Number: 5954450
• Device Lot Number: HUBW0142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2017
• 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