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

Catalog Number 5955600

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Confirmed for use related issue.The sample evaluation confirms for the reported condition of separation of the hydrogel from the mesh.Based on the sample evaluation it appears that the mesh was not hydrated prior to insertion.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 to stick to the hydrated portion making deployment and placement difficult and causing separation of the hydrogel barrier.The sample evaluation found no manufacturing anomalies.Per the instructions-for-use "the ventralight st mesh with echo ps positioning system should be hydrated for no more than 1 -3 seconds just prior to laparoscopic placement.The ventralight st with echo ps positioning system must be rolled immediately after hydration." a review of the manufacturing records was performed, no manufacturing issues associated to the reported event were found in the reviewed lot.All process steps were completed per manufacturing and inspection procedures.Product passed all required inspections at both end product and subassembly levels.There was no rework or other manufacturing abnormalities that may have contributed to this complaint.Additionally, to date this is the only reported complaint for this production lot of (b)(4) units released for distribution in may, 2018.

Event Description

It was reported that during a robotic ventral hernia repair the surgeon prepared the ventralight st mesh w/ echo ps by rolling properly and inserting through a 12mm trocar port, and when the mesh unfurled for placement the surgeon noted the st portion of the mesh was "falling apart." the mesh and the echo ps were removed entirely and a new mesh was used to complete the repair with no further issue.There was no patient injury.The surgeon is reported to be a very experienced echo user.The contact was not entirely sure if the surgeon hydrated the mesh in this particular case but did indicate it is his common practice to not hydrate the mesh prior to rolling and insertion.

• Brand Name: VENTRALIGHT ST W/ ECHO
• 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: 7970965
• MDR Text Key: 123961045
• Report Number: 1213643-2018-03575
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031731
• UDI-Public: (01)00801741031731
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130968
• 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: 10/16/2018

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: 04/28/2020
• Device Catalogue Number: 5955600
• Device Lot Number: HUCP2431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2018
• Initial Date FDA Received: 10/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2018
• 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