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

Catalog Number 5955790

Device Problems Material Separation (1562); Failure to Unfold or Unwrap (1669)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2021

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 280579804
• Report Number: 1213643-2021-20401
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 5955790
• Device Lot Number: HUEY0842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Date Manufacturer Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/10/2021 Patient Sequence Number: 1