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

Catalog Number 5950008

Device Problems Material Disintegration (1177); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problems Wound Dehiscence (1154); Pain (1994); Hernia (2240)

Event Date 08/06/2019

Event Type  Injury  

Manufacturer Narrative

No conclusion can be made.The contact reports that the patient's current surgeon, who assessed the issues has indicated that "it appears the defect was not sufficiently closed during the initial procedure, which may have led to the budge." however, at this time, based on the information provided, a cause for the reported patient condition has not been determined.Recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reaction section of the instructions-for-use as a possible complication.A lot number was not provided, without a lot number a review of the manufacturing records is not possible.Note the date of implant is estimated based on the information provided as an exact date of implant was not reported.Should additional information be provided, a supplemental emdr will be submitted.Remains implanted.

Event Description

It was reported that in (b)(6) 2017 the patient underwent hernia repair with the implant of a bard/davol ventralex st mesh.As reported, the patient subsequently experienced a wound dehiscence, a bulge at the area of the initial repair and chronic pain.As reported at times the pain prevents the patient from walking around.The contact reports that the patient's current surgeon, who assessed the issues has indicated that "it appears the defect was not sufficiently closed during the initial procedure, which may have led to the budge." the contact reports that the patient will undergo an additional surgery, however has not provided any specific timeframe or date in which this will take place.

Event Description

It was reported that in february 2017 the patient underwent hernia repair with the implant of a bard/davol ventralex st mesh.As reported, the patient subsequently experienced a wound dehiscence, a bulge at the area of the initial repair and chronic pain.As reported at times the pain prevents the patient from walking around.The contact reports that the patient's current surgeon, who assessed the issues has indicated that "it appears the defect was not sufficiently closed during the initial procedure, which may have led to the budge." the contact reports that the patient will undergo an additional surgery, however has not provided any specific timeframe or date in which this will take place.Addendum: (b)(6) 2017 - patient underwent implant of a bard/davol ventralex st medium mesh.2017- the patient first went to the primary doctor with complaints about the mesh, which started a few months after the implant.The patient could not perform usual activities; the patient was in shape and a swimmer previously.After the mesh implant, the patient put on weight, had muscle and bone weakening.The patient was given an mri and x-ray, and was referred to a specialist.(b)(6) 2019 - patient underwent additional surgery, the bard/davol ventralex st not explanted.As reported, the patient was told the mesh was disintegrated, had a large patch (unknown mesh) put in over the bard/davol mesh.

Manufacturer Narrative

No conclusion can be made.The contact reports that the patient's current surgeon, who assessed the issues has indicated that "it appears the defect was not sufficiently closed during the initial procedure, which may have led to the budge." however, at this time, based on the information provided, a cause for the reported patient condition has not been determined.Recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reaction section of the instructions-for-use as a possible complication.A lot number was not provided, without a lot number a review of the manufacturing records is not possible.Note the date of implant is estimated based on the information provided as an exact date of implant was not reported.Addendum: this is an addendum to the initial mdr.This supplemental emdr is submitted to report additional event information received and correct the date of implant.The additional information provided does not change the initial determination; the cause of the patient¿s reported postoperative conditions cannot be determined.Should additional information be provided, a supplemental emdr will be submitted.Remains implanted.

• 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: 8584244
• MDR Text Key: 144241622
• Report Number: 1213643-2019-03644
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031489
• UDI-Public: (01)00801741031489
• 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
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5950008
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR