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

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.

• 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 sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6944286
• MDR Text Key: 90311297
• Report Number: 1213643-2017-00679
• 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: 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 Received: 10/12/2017
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 08/28/2018
• Device Catalogue Number: 5950050
• Device LOT Number: HUAU1604
• 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 Received: 10/09/2017
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 09/11/2016
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial