MAUDE Adverse Event Report: BARD SHANNON LIMITED 3005636544 VENTRALIGHT ST MESH; SURGICAL MESH

Catalog Number	5954600
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information available, a definitive root cause for the material separation cannot be made.The mesh remains implanted in the patient and is not available for review.However, an intraoperative photo was provided, confirming there was some separation of the st coating from the mesh.Per the laparoscopic use section in the instructions-for-use, "the "ventralight¿ st mesh should be hydrated for no more than 1-3 seconds just prior to laparoscopic placement.If sutures are being placed, attach the sutures to the ventralight¿ st mesh before hydration.The prosthesis must be rolled immediately after hydration about its long axis (lengthwise) with the bioresorbable coating inside to protect the bioresorbable coating." additionally, the instructions-for-use recommends the use of a 10mm trocar size for the product code used.It is possible that over-hydration and/or the size of trocar used for the procedure contributed to the material separation.Additional information was requested about the case.It was confirmed that they hydrated the mesh but could not provide the length of time.The size of trocar used was not provided.Over hydration can result in material disruption.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 (b)(4) units released for distribution in july 2019.Should additional information be provided, a supplemental emdr will be submitted.Not returned - remains implanted.
Event or Problem Description
As reported, during a robotic umbilical hernia repair procedure using a ventralight st mesh, the surgeon rolled the mesh, inserted it through the trocar and unrolled it to place it on the defect.Within moments of getting it positioned, the yellow ¿adhesion barrier ring (st coating)' separated from the mesh.The surgeon did not attempt to remove it, but managed to place the mesh over the defect.As reported, there was no patient injury and no post-op complications.

• Brand Name: VENTRALIGHT ST MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): BARD SHANNON LIMITED 3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• MDR Report Key: 10104814
• Report Number: 1213643-2020-05187
• Device Sequence Number: 11439733
• Product Code: FTL
• UDI-Device Identifier: 00801741031632
• UDI-Public: (01)00801741031632
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2021
• Device Catalogue Number: 5954600
• Device Lot Number: HUDR2292
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1