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

Catalog Number UNKAA078

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problems Abscess (1690); Disability (2371); Bowel Perforation (2668)

Event Date 03/03/2018

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made.The patient's attorney alleges bowel perforation, disability, mesh detachment, abcess, infection, fistula, disfigurement and subsequent surgical intervention, however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Should additional information be provided a supplemental emdr will be submitted.Not returned.

Event Description

Attorney alleges that on (b)(6) 2012, the patient underwent a ventral hernia repair.Per the operative report, an unspecified bard/davol ventralight st was used as an underlay and an unspecified bard/davol xenmatrix was used as an overlay to repair the hernia defect.The patient was admitted on (b)(6) 2018; the admitting physician reported that "plaintiff presents with 2 months of persistent drainage through a small midline abdominal wound.He states that the drainage is foul smelling but does not look like stool.He denies fever or chills.He came into the emergency room this evening because the drainage increased.Ct imaging demonstrates a large abdominal wall abscess containing fluid, debris and air.Most recently, the patient underwent a ventral hernia repair with mesh 6 years ago in kansas." on (b)(6) 2018, the patient underwent incision and drainage of abdominal wall abscess with intraabdominal exploration and drain control of enterocutaneous fistula and subtotal removal of mesh with wound vac placement.During this procedure, the operating physician made the following findings: "recommendation is made for initial incision drainage of the abdominal wall abscess.Patient was informed that he will need multiple surgical procedures to deal with presumed infected mesh and possible enterocutaneous fistula.There was evidence of a prior ventral hernia repair with mesh that appeared to be bridged repair, and therefore upon opening the skin at the site of the drainage, we were into the peritoneal cavity as the mesh bridging this defect was completely non-­incorporated and essentially floating in the wound.There was peripheral fixation of the intraperitoneal underlay mesh, however.The enterocutaneous fistula was identified deep to the mesh with an approximate 5mm diameter of the opening in the small bowel.The abdominal viscera were essentially all plastered together and not discretely discernable." later during the procedure, the surgeon noted "i could see completely unincorporated loose mesh floating in the middle of the wound.Continued exploration was performed.I divided the unincorporated mesh and excised most of the mesh.The periphery of the mesh where it had either been fixated or was incorporated, i left portions of the mesh in place today as further surgery is clearly going to be necessary.I did not want to risk small bowel injury trying to free incorporated mesh from the lateral aspects of the repair.I also wanted to leave enough mesh behind this so that it can be clearly visualized, and no infected mesh inadvertently left in place." further, on (b)(6) 2018, the patient underwent an abdominal washout, excision of mesh and placement of a wound vac.During that procedure, part of the mesh was debrided and a foley catheter was placed in the fistula.On (b)(6) 2018, the patient had an exploratory washout of abdominal wound, control of bleeding and placement of wound vac.The patient was released from the hospital on (b)(6) 2018, and was subsequently transferred to another facility for wound care.It is alleged that the mesh caused serious injury and had to be surgically removed via invasive surgery to repair the hernia that the ventralight st was initially implanted to treat.It is also alleged that the patient had suffered, and will continue to suffer, both physical injury and pain and mental anguish, permanent and severe scarring and disfigurement.Attorney also alleges that the patient experienced emotional distress and the device was defective.

• Brand Name: VENTRALIGHT ST MESH
• 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 9835127
• MDR Text Key: 188799971
• Report Number: 1213643-2020-02580
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA078
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2020
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability