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

Catalog Number 5954680

Device Problems Material Discolored (1170); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

The sample was not returned for evaluation.However based on the events as reported the user failed to hydrate the mesh per the instructions-for-use.If the mesh is not hydrated per the instructions-for-use, portions of the hydrogel can become hydrated by bodily fluids during insertion.When this happens the dry portion of the hydrogel barrier will stick to the hydrated portion making deployment and placement difficult and causing separation of the hydrogel barrier.Also reported was that the hydrogel appeared to have changed color.Color variation is a known condition that presents normally in use, and is not function related.The color variation can be more noticeable in laparoscopic procedures due to a combination of factors related to the camera and reflection of the light source within the abdominal cavity.This complaint is confirmed as use related.Per the instructions-for-use: "ventralight st mesh should be hydrated for no more than 1-3 seconds just prior to laparoscopic placement.The prosthesis must be rolled immediately after hydration about its long axis (lengthwise) with the bioresorbable coating inside to protect the bioresorbable coating." a review of the manufacturing records was performed and found that the lot was manufactured to specification.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.Implanted.

Event Description

It was reported that on (b)(6) 2018 a davol ventralight st mesh was used during a laparoscopic ventral hernia repair procedure.As reported the surgeon closed the defect, rolled the mesh with the hydrogel (st) inwards (without first hydrating the mesh) and introduced the mesh through the trocar.It is reported that while unrolling the mesh intra-abdominally the mesh stuck to itself.While manipulating the mesh to detach it from itself it was reported that some parts of the hydrogel detached from the mesh.Additional it is reported that the hydrogel appeared to have turned yellow and the mesh became rigid.However, the surgeon chose to implant the mesh, which was fixated with a non-davol mechanical fixation device.

• 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: 7612912
• MDR Text Key: 111433630
• Report Number: 1213643-2018-02028
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031656
• UDI-Public: (01)00801741031656
• Combination Product (y/n): N
• PMA/PMN Number: K101851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Catalogue Number: 5954680
• Device Lot Number: HUCP0326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2018
• 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: 65 YR
• Patient Weight: 79