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

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).

• Brand Name: VENTRIO MESH
• Type of Device: SURGICAL 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 Key: 5443602
• MDR Text Key: 38415868
• Report Number: 1213643-2016-00054
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 0010218
• Device Lot Number: HUZE1337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1