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

Catalog Number 5950060

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2016

Event Type  malfunction  

Manufacturer Narrative

As reported the mesh ripped while attempting to place in the patient during a ventral hernia repair procedure.Additional event information has been requested.Additionally, 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 a supplemental mdr will be submitted to document our findings.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: on (b)(6) 2016 it is reported that during a ventral hernia repair procedure, as the surgeon placed the mesh in the patient the bard ventrio st mesh "ripped." another mesh was used to complete the case without issue.There was no injury to the patient.

Manufacturer Narrative

This is an addendum to the initial mdr to document the receipt and evaluation of the sample.Visual examination found the pdo ring to be intact and completely contained within the containment sleeve.A small portion of the mesh pocket was found to be torn away allowing a section of the containment sleeve to extend beyond the mesh pocket.There were no other anomalies noted to the mesh sample and there were no detached components of the mesh.A review of the manufacturing records was performed and found that the lot was manufactured to specification.The damage most likely occurred during manipulation as this was not an out of box reported condition.The sample was received heavily contaminated and folded in half.Based on the events as reported and the sample evaluation, the condition of the sample appears to have occurred during user/device interface.

Event Description

The following was reported to davol.On (b)(6) 2016 it is reported that during a ventral hernia repair procedure, as the surgeon placed the mesh in the patient, the bard ventrio st mesh "ripped." another mesh was used to complete the case without issue.There was no injury to the patient.

• Brand Name: VENTRIO ST
• 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: 5869150
• MDR Text Key: 51862126
• Report Number: 1213643-2016-00378
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101920
• 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: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• Device Catalogue Number: 5950060
• Device Lot Number: HUZJ0736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2016
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2016
• 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
• Patient Age: 65 YR