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

Catalog Number 5950030

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)

Patient Problems Abscess (1690); Unspecified Infection (1930); Necrosis (1971); Hernia (2240)

Event Date 09/30/2013

Event Type  Injury  

Manufacturer Narrative

No conclusions can be made. The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including disability, hernia recurrence, infection, abscess and subsequent surgical intervention for mesh removal. The instructions-for-use (ifu) supplied with the device lists hernia recurrence, infection, adhesions, inflammation as possible complications. A review of the manufacturing records was performed and found that the lot was manufactured to specification. In regards to the infection, the warnings section of the ifu states "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the prosthesis. An unresolved infection may require removal of the prosthesis. " should additional information be provided, a supplemental emdr will be submitted. Not returned.

Event Description

Attorney alleges that on or about (b)(6) 2012, the patient underwent repair of an abdominal hernia and was implanted with a bard/davol ventrio st mesh. It is alleged that on or about (b)(6) 2013 and (b)(6) 2014, the patient underwent additional surgeries to revise the ventrio st mesh. Attorney alleges that on or about (b)(6) 2015, the patient underwent surgery to revise the ventrio st mesh and a non-bard/davol mesh was implanted during this procedure. It is alleged that on or about (b)(6) 2019, the patient underwent additional surgeries to partially remove the mesh products. It is alleged that the patient experienced and/or continues to experience severe and chronic pain/discomfort, inflammation, torn mesh, dense adhesions, mesh detachment, infection, ulceration, dense scarring, open draining wound, abdominal wall reconstruction, necrosis, abscess, and recurrence. It is alleged that the patient is at a higher risk of severe complications during an abdominal surgery, to the extent that future abdominal operations might not be feasible. Attorney alleges that the ventrio st mesh implanted in patient failed to reasonably perform as intended, caused serious injury and had to be surgically removed via invasive surgery, and necessitating additional invasive surgery to repair the hernia that the ventrio st mesh was initially implanted to treat. Attorney alleges past, present, and future damages, that the patient has been injured, sustained severe and permanent pain, suffering, disability, impairment, mental anguish and emotional distress. It is also alleged that the device was defective.

• 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 12661821
• MDR Text Key: 277476988
• Report Number: 1213643-2021-08196
• 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: consumer,other

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 08/28/2013
• Device Catalogue Number: 5950030
• Device Lot Number: HUVH0741
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/19/2021 Patient Sequence Number: 1