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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. VENTRIO MESH SURGICAL MESH Back to Search Results
Catalog Number 0010212
Device Problems Hole In Material (1293); Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

As reported the user experienced difficulty when attempting to insert the device into the trocar. It is not known what size trocar was used. Multiple attempts were made to gather more information but there was no response to our request to date. The instructions-for-use state, "for laparoscopic procedures, all size patches should be rolled into thirds along the long axis, eptfe side out, and inserted through a trocar site which is a minimum of 12mm (remove trocar, insert mesh, and reinsert trocar). " visual examination of the returned samples confirms the report that the user attempted to place the mesh, based on physical condition. Multiple device interface marks are present and it appears that a grasper was used during attempted insertion. The forces applied to the device during the attempted implantation appear to have caused a hole to present in the eptfe layer. This was not reported as an out of the box condition and no manufacturing issues were noted during the sample evaluation. To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in (b)(4) 2017. Based on the sample evaluation it appears that the damage to the device was due to user/device interface inadvertently damaging the implant. No manufacturing or material anomalies were found. 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

As reported the user experienced difficulty when attempting to insert the bard ventrio hernia patch into the trocar of the coelioscopy. There was no patient adverse outcome reported as a result of this event. The sample was returned to davol and the evaluation noted a hole in the eptfe layer which appears to have been made during attempted insertion into the trocar. A hole in the eptfe layer could impact the ability of the device to perform as intended if used, and could increase the risk of post operative complications and adhesion formation as such an mdr is filed to document this event.

 
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Brand NameVENTRIO 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 sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key7025891
MDR Text Key92863955
Report Number1213643-2017-00847
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK100229
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation PHARMACIST
Type of Report Initial
Report Date 11/13/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/13/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/28/2020
Device Catalogue Number0010212
Device LOT NumberHUAY2591
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/27/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/16/2017
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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