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

Catalog Number 5954600

Device Problem Material Separation (1562)

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

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

As reported, the sepra (st) coating of the ventralight st mesh separated during attempted deployment via an 8mm trocar (note, per the ifu a 10mm trocar is recommended for cat# 5954600). The subject product was returned for evaluation. Evaluation of the sample finds the st coating to have separated from areas on the mesh, resulting in a void of the hydrogel barrier. The separation of the hydrogel coating is the result of the attempted deployment through the 8mm trocar. The trocar used in the case was also returned with the mesh sample and is confirmed to be an 8mm trocar. Based on the sample evaluation and investigation performed, the root cause is determined to be inadvertent damage to the st hydrogel barrier during user/device interface while handling the hydrated mesh and deploying down the 8mm trocar. To date, this is the only reported complaint for this manufacturing lot. Per the laparoscopic use section in the instructions-for-use, ¿a minimum sized trocar is recommended for the laparoscopic delivery of ventralight st mesh (recommended to use a 10mm trocar for cat# 5954600). Insert the prosthesis through the trocar using a rigid instrument, such as non-serrated, 5 mm forceps; do not over force the prosthesis through trocar. 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. ".

Event Description

As reported, during a laparoscopic ventral hernia repair procedure on (b)(6) 2021, the bard/davol ventralight st mesh was hydrated approximately 1-3 seconds, rolled with the st coating inside and inserted through an 8 mm trocar. As reported, when the surgeon unrolled the mesh, the st coating was noted to be separating. As reported, the mesh was removed and a non-bard/davol mesh was used to complete the procedure. 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: 12396526
• MDR Text Key: 269402760
• Report Number: 1213643-2021-20290
• Device Sequence Number: 1
• Product Code: FTL
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 5954600
• Device Lot Number: HUFN0308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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: 08/31/2021 Patient Sequence Number: 1