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

Catalog Number 5954450

Device Problem Material Separation (1562)

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

Event Date 05/27/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned and has been evaluated.No manufacturing anomalies were found.Evaluation finds the st hydrogel barrier is separated from areas on the mesh, resulting in a void of the st hydrogel barrier.Evaluation identified that the mesh had been hydrated by the user, how long the mesh had been hydrated for is unknown.Sutures were placed in the mesh during preparation for use, however, it is unknown if the sutures were placed prior to hydration, as recommended.The issue that presented was not reported as an out of box condition.Based on the information provided and sample evaluation, the root cause is determined to be inadvertent damage to the st hydrogel barrier during user/ device interface while handling the hydrated mesh.The instructions-for-use (ifu) states that sutures are to be placed before hydration; the mesh should be hydrated for no more than 1-3 seconds prior to use and rolled immediately to protect the bioresorbable coating.A minimum trocar size of 10mm is recommended for product code 5954450.If ventralight st mesh is hydrated longer than 3 seconds and/or does not easily deploy down the trocar, replace trocar and retry with the next available larger sized trocar.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 for this manufacturing lot of 413 units released for distribution in january, 2021.

Event Description

As reported, upon insertion of bard/davol ventralight st mesh on (b)(6) 2021, "there was a lot of gel residue found that did not feel right".There was no reported patient injury.

• Brand Name: VENTRALIGHT ST MESH
• 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: 11991620
• MDR Text Key: 255967505
• Report Number: 1213643-2021-20149
• 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: other,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2022
• Device Catalogue Number: 5954450
• Device Lot Number: HUEY0475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Date Manufacturer Received: 05/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2021
• 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 Outcome(s): Other