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

Catalog Number 5950007

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Device (2588); Detachment of Device or Device Component (2907)

Patient Problems Abdominal Pain (1685); Unspecified Infection (1930); Pain (1994); Injury (2348); Disability (2371)

Event Date 08/16/2017

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.To date medical records provided have been limited to the implant tracking log.The information provided alleges that the "ventralex st mesh is not adhering and a revision surgery is necessary." the instructions-for-use adequately prescribes the proper method of implantation for this device to prevent damage to the product and injury to the patient.A sample was not provided for further evaluation.Based on the limited information provided and the patient's pre-existing condition, no conclusions can be made between the reported post-operative complications and the bard/davol ventralex st.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.Not returned.

Event Description

The following was alleged by the patient's attorney and implant tracking log: on (b)(6) 2017 - the patient underwent open umbilical hernia repair in which a bard/davol ventralex st was used.As reported, "subsequent to the surgery of (b)(6) 2017, the patient began to have fatigue, severe abdominal pain, loss of appetite and vomiting.Patient has been advised that the bard/davol ventralex st mesh is not adhering and a revision surgery is necessary." as alleged, the patient "has suffered great bodily injury, resulting in pain and suffering, disability, disfigurement, aggravation of a pre-existing condition and medical and nursing care treatment.".

Manufacturer Narrative

Addendum to the initial report.This supplemental emdr is being sent to provide additional patient and medical information taken from the patient's medical records.Medical record provided indicate that the patient developed a post implant operative wound infection.While there is no indication the bard/davol ventralex st mesh caused or contributed to the infection, the warning section of the instructions-for-use 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.¿ the infection resolved without need to remove the mesh.Approximately 6 months post implant of the bard/davol ventralex st mesh, the patient developed an abdominal hernia.There is no indication in the provided medical records, if this hernia is a possible recurrence of the previously treated hernia or even in the same area, however, recurrence is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication.With the current information available, the conclusion for this file remains inconclusive.Note: section a through f - 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.

Event Description

As was originally reported in 06/2018: (b)(6) 2017 - the patient underwent open umbilical hernia repair in which a bard/davol ventralex st was used.As reported, "subsequent to the surgery of (b)(6) 2017, the patient began to have fatigue, severe abdominal pain, loss of appetite and vomiting.Patient has been advised that the bard/davol ventralex st mesh is not adhering and a revision surgery is necessary." as alleged, the patient "has suffered great bodily injury, resulting in pain and suffering, disability, disfigurement, aggravation of a pre-existing condition and medical and nursing care treatment." addendum based on additional medical records received: (b)(6) 2017 - the patient returned postoperatively to md with erythema and tenderness at the site for the past 48 hours.Md exam revealed a small amount of drainage and the wound dressing was stained.Md notes there is possible cellulitis or bruising from the injection site.(b)(6) 2017 - the patient had an md follow up office visit with a wound infection that was being followed by the surgical team and had completed a course of antibiotics.The patient continued to complain of pain and nausea.(b)(6) 2017 - the patient had an md follow up office visit with complaints of pain and periumbilical discomfort.Per the md exam notes, "wound infection resolving." the patient was advised to follow up with general surgery.(b)(6) 2018 - the patient continues to report having pain at the incision site 6 months later.Md diagnosed the patient with an abdominal hernia and referred him for general surgery.

• 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
• MDR Report Key: 7616493
• MDR Text Key: 111611528
• Report Number: 1213643-2018-02059
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031472
• UDI-Public: (01)00801741031472
• Combination Product (y/n): N
• PMA/PMN Number: K101928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2019
• Device Catalogue Number: 5950007
• Device Lot Number: HUAZ1534
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 39 YR
• Patient Weight: 90