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

Catalog Number	5954600
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 12396526
• Report Number: 1213643-2021-20290
• Device Sequence Number: 4724240
• Product Code: FTL
• UDI-Device Identifier: 00801741031632
• UDI-Public: (01)00801741031632
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2021

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: 12/28/2022
• Device Catalogue Number: 5954600
• Device Lot Number: HUFN0308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other