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

Catalog Number 0010301

Device Problems Material Separation (1562); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The reporter was unable to provided clarification of the report that the mesh "fell apart." it is reported that the sample is being returned for evaluation; however has not been received to date.At this time no conclusions can be made.If / when the sample is returned and the evaluation has been completed a supplemental mdr will be submitted.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

It was reported that while attempting to use a bard ventralex hernia patch it "fell apart." there was no patient injury and as reported the sample is being returned for evaluation.

Manufacturer Narrative

A review of the manufacturing records found that the product passed all required inspections at both end product and subassembly levels.No manufacturing issues associated to the reported event were found in the reviewed lot.To date this is the only reported complaint for this manufacturing lot of 302 units released for distribution on 01/14/2015.As reported the mesh "fell apart" the contact stated that no additional information could be provided.The sample evaluation found that the positioning straps had been cut from the device and the positioning pocket mesh, was torn.Also noted were severe grasper marks on, and stretching of, the eptfe layer.Additionally, it appears that during attempted implantation of the device the user folded the patch in, towards the eptfe layer, not facing out as is instructed in the ifu.The labeling review found that the ifu states to ¿roll the patch parallel to the opening between the straps with the eptfe side facing out for insertion into the defect.The free or unattached end of the positioning strap is left outside of the body during placement.The positioning strap is manipulated to facilitate the proper positioning of the patch.Gently pull up on the positioning strap, which will allow the patch to flatten itself against the underside of the abdominal wall.¿ the incorrect folding and forces applied during use appears to have led to a combination of factors causing the mesh to tear.This complaint is confirmed for user device interface.

• Brand Name: MESH -VENTRALEX
• 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: 6389090
• MDR Text Key: 69446662
• Report Number: 1213643-2017-00161
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2018
• Device Catalogue Number: 0010301
• Device Lot Number: HUYK0675
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2017
• 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