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U.S. Department of Health and Human Services

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

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BARD SHANNON LIMITED 3005636544 VENTRALIGHT ST MESH SURGICAL MESH Back to Search Results
Catalog Number 5954600
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/14/2020
Event Type  Malfunction  
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 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.

 
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Brand NameVENTRALIGHT ST MESH
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
BARD SHANNON LIMITED 3005636544
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
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
4018258495
MDR Report Key10104814
MDR Text Key193038610
Report Number1213643-2020-05187
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK101851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 05/29/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/01/2020
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5954600
Device LOT NumberHUDR2292
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/26/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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