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

Catalog Number 0010303

Device Problems Folded (2630); Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problems Purulent Discharge (1812); Fistula (1862); Unspecified Infection (1930)

Event Date 09/14/2010

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, no definitive conclusions can be made.Without medical records it is unknown what "complications" presented during the implant procedure.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Fistula formation is listed as a possible complication in the adverse reaction section of the ifu.Regarding infection the warning section states, "if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however may require removal of the prosthesis." it is reported that within two weeks of being implanted the patch became detached from the abdominal wall and adhered to the patient's bowel.The fixation technique used to secure the device is unknown as medical records have not been provided.Regarding fixation the warning section of the ifu states, "to ensure a strong repair, the prosthesis should be secured with tacks or sutures through the polypropylene mesh straps and/or positioning pocket.Suturing or tacking on the sealed edge of the mesh alone is not recommended." if additional information is obtained, 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.Not returned.

Event Description

The following was reported to davol by the patient: on (b)(6) 2010 - the patient underwent a laparoscopic incisional hernia repair with implant of a bard ventralex hernia patch.The patient stated the attending surgeon informed his wife that there had been some "complications" during the procedure; however, did not give any details as to what had occurred.The patient also stated he was not put on any antibiotics postoperatively for prevention of infection.On (b)(6) 2010 - the patient presented to the er with left abdominal incision site drainage; there was a foul smelling purulent discharge and redness.A ct scan showed an abscess and fistula formation due to the mesh becoming detached from the abdominal wall, folding over and adhering to the small bowel.He reports that he was diagnosed with a "mesh infection" and underwent an additional surgical procedure which included removal of the bard ventralex hernia patch, a small bowel resection and the implant of a non bard/davol biologic graft.On (b)(6) 2010 - the patient underwent multiple wound care procedures which included wound debridement of excessive amounts of necrotic tissue and wound dressing changes.

• 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: 5754797
• MDR Text Key: 48314446
• Report Number: 1213643-2016-00291
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K021736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: 0010303
• Device Lot Number: HUTL0027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/07/2016
• Initial Date FDA Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2009
• 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 Outcome(s): Required Intervention
• Patient Age: 66 YR