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

Catalog Number UNKAA086

Device Problems Material Separation (1562); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

Based on the event as reported, the user experienced difficulty when attempting to fixated the mesh, which caused small tears in the hydrogel barrier only.As reported the mesh was implanted in the patient and the surgeon states this event did not "affect the integrity of the mesh." this was not reported an out of box event and there is no indication that nonconforming product was provided to the customer.The hydrogel barrier is designed to be completely resorbed from the site within 30 days of implant.The mesh remains implanted and there has been no reported patient injury as a result of this event.A lot number was not provided therefore a review of the manufacturing records is not possible.Should additional information be provided, a supplemental emdr 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.Remains implanted.

Event Description

As reported per facility contact on or about (b)(6) 2018 a ventralex st implant was damaged during placement.It was reported that the implant was torn during fixation with optifix.In follow up with the surgeon it was later stated that there were a few, ¿small tears¿ on the posterior side or the mesh, which in his opinion did not affect the integrity of the mesh.The device was implanted.The tears are roughly the diameter of a fastener.The tm explained to the surgeon the pga component layer over the polypropylene mesh.The surgeon believes the area he describes as torn was pga material separation and not torn polypropylene mesh.

• Brand Name: VENTRALEX 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: 7730923
• MDR Text Key: 115358967
• Report Number: 1213643-2018-02531
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA086
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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