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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST MESH SURGICAL MESH Back to Search Results
Catalog Number 5954460
Device Problems Material Separation (1562); Sticking (1597)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/16/2015
Event Type  malfunction  
Manufacturer Narrative
On receipt of the sample it was noted that there were areas of the mesh with voids in the hydrogel coating. As was reported the visual examination finds sections of the hydrogel coating stuck together. The surgeon had affixed a suture prior to deployment and that bunched the material together creating a crease, thus folding the material against itself. The problem experienced by the user appears to have been due to the manner in which the implant was folded coating side to coating side resulting in the hydrogel sticking together in a manner that compromised the barrier when unfolded after deploying into the body. Examination of the mesh found no anomalies. The evaluation finds the issue experienced appears to be related to user device interface. The ifu prescribes that the ventralight st 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 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. A minimum sized trocar is recommended for the laparoscopic delivery of ventralight st mesh. Insert the prosthesis through the trocar using a rigid instrument such as non-serrated, 5mm 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 and retry with the next available larger sized trocar. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
The following was reported to davol: as reported, the surgeon attempted to place the ventralight st mesh in the patient but the mesh became stuck together and could not be used. The procedure being performed was a laparoscopic incisional hernia repair, the device was not hydrated and the issue occurred during placement. There was no patient injury and another mesh was used to complete the case.
 
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Brand NameVENTRALIGHT ST MESH
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
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
laura berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key5364215
MDR Text Key35815613
Report Number1213643-2016-00014
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 12/23/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2017
Device Catalogue Number5954460
Device Lot NumberHUZF1643
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received12/23/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2015
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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