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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. VENTRIO ST SURGICAL MESH Back to Search Results
Catalog Number 5950050
Device Problem Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/06/2017
Event Type  Malfunction  
Manufacturer Narrative

The subject product was not available for evaluation. This is the first reported complaint for the subject lot of (b)(4) units manufactured in september, 2016. Based on the information currently available, no conclusion can be drawn. As reported there was device to device interface and the forces applied may have contributed to the problem experienced. If additional information is provided, a supplemental mdr will be submitted. This report represents the ventrio st (device #1). An additional mdr will be submitted to represent the enhanced sorbafix device used (device #2). Of 3500a report ((b)(4)) provided to davol by the user facility. 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. Device implanted.

 
Event Description

It was reported that during a laparoscopic repair of a recurrent incarcerated incisional hernia using a bard/davol ventrio st mesh (device #1) and the bard/davol sorbafix fixation device (device #2), the fixation device deployed two fasteners at once and then would not deploy at all. A fastener was fired through the entire mesh and the head broke off of the fastener and the fastener fell into the abdomen. All loose pieces were retrieved. Another sorbafix was used to complete the case. The surgeon is an experienced user of the device. There was no delay to the procedure and no patient injury was reported. As the problem reported resulted in a hole in the ventrio st mesh material there was some compromise to the implants adhesion barrier. Although this is unlikely to result in patient harm, there is a potential incremental risk to the patient and an mdr is being filed to report the malfunction.

 
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Brand NameVENTRIO ST
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 Key6944286
MDR Text Key90311297
Report Number1213643-2017-00679
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK101920
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER,USE
Reporter Occupation
Type of Report Initial
Report Date 10/12/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/12/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/28/2018
Device Catalogue Number5950050
Device LOT NumberHUAU1604
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/11/2016
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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