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

Catalog Number	5955790
Medical Device Problem Codes	Material Separation (1562); Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a robotic-assisted laparoscopic ventral hernia repair procedure on (b)(6) 2021, when the bard/davol ventralight st mesh w/echo ps was inserted through the trocar, the mesh edge was stuck to itself and would not fully open.As reported, the mesh was removed and another mesh was used to complete the case.As reported, the surgeon is an experienced user and there was no patient harm or injury.
Additional Manufacturer Narrative
The subject device was returned and has been evaluated.Visual evaluation confirms a section of the hydrogel coating is stuck together transferring the hydrogel material.A void was noted in the material, however hydrogel was still present where the hydrogel material stuck together.No manufacturing anomalies were found.It is unknown if the mesh was hydrated prior to use.Implantation of a non-hydrated mesh may result in the hydrogel becoming hydrated from body fluids resulting in a hydrated and a dry section of the barrier sticking together.This can result in the separation of the barrier.The instructions-for-use, supplied with the device, state the mesh should be hydrated for no more than 1-3 seconds prior to use and rolled immediately to protect the bioresorbable coating, and recommends the use of a 12mm trocar size for the product code used.Based on the sample evaluation and investigation performed, the most probable root cause is an event occurring during user /device interface during deployment.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in jan, 2021.

• Brand Name: VENTRALIGHT ST W/ ECHO
• Common Device Name: 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: 12786217
• Report Number: 1213643-2021-20401
• Device Sequence Number: 5155862
• Product Code: FTL
• UDI-Device Identifier: 00801741031762
• UDI-Public: (01)00801741031762
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2022
• Device Catalogue Number: 5955790
• Device Lot Number: HUEY0842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown