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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 0010218
Device Problems Misassembled (1398); Product Quality Problem (1506)
Patient Problems Hernia (2240); No Known Impact Or Consequence To Patient (2692)
Event Date 11/12/2015
Event Type  malfunction  
Manufacturer Narrative
Sample was returned for evaluation. It was determined that the unit was not properly orientated when assembled. The slit mesh (positioning pocket created during manufacturing) was on the bottom and the mesh layer on the top was not open. We have concluded that this problem was caused by an operator error. Per manufacturing process requirement the positioning pocket should have been placed on the top and the non-slit mesh on the bottom. By altering the mesh as the surgeon did he inadvertently weakened the device and compromised its effectiveness. The warning section of the ifu states, "do not cut or reshape the ventrio¿ hernia patch, as this could affect its effectiveness. ¿ regarding fixation the ifu states, "davol fixation devices and/or non-absorbable monofilament sutures are recommended to properly secure the prosthesis. If other fixation devices are used, they must be indicated for use in hernia repair. Care should be taken to ensure that the patch is adequately fixated to the abdominal wall. If necessary, additional fasteners and / or sutures should be used. " while the device was compromised by the alteration by the user this does not appear to have caused the post-op complications that were related to the patient's recurrent hernia. The recurrence was reported to have been caused by the surgeon being unable to adequately fixate the mesh due to the patient¿s anatomy and that the mesh used being undersized to the hernia defect. This mdr represents the manufacturing deficiency noted during the sample evaluation. A separate mdr (1213643-2015-00432) was previously sent to report the unrelated post operative recurrence. 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: contact reported that the bard/davol ventrio hernia patch when removed from the package did not contain the positioning pocket, which is a slice that is cut into one layer of the mesh to assist with the positioning of the implant. The surgeon chose to alter the device by cutting the outer layer of the mesh to create this pocket. As reported the surgeon was not able to achieve a good level of fixation due to patient anatomy and he felt that there was "insufficient" fixation. Shortly after the procedure that patient experienced a recurrent hernia that required additional surgery. The surgeon reported that the adverse outcome was associated with the insufficient fixation of the mesh along with the mesh itself not being large enough to adequately address the defect. As reported the post-op complications were unrelated to the problem initially experienced with the mesh non conformance.
 
Manufacturer Narrative
This follow-up mdr is being submitted as a result of a retrospective review of davol's mdr files. Corrected field: this mdr represents the manufacturing deficiency noted during the sample evaluation. A separate mdr (1213643-2015-00432) was previously sent to report the unrelated post operative recurrence. Code change to (b)(4).
 
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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 berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key5443602
MDR Text Key38415868
Report Number1213643-2016-00054
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K100229
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Catalogue Number0010218
Device Lot NumberHUZE1337
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received05/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/16/2015
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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