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

Catalog Number 5950009

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907); Material Deformation (2976); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems Abdominal Pain (1685); Pain (1994); Scar Tissue (2060); Scarring (2061); Hernia (2240)

Event Date 03/30/2016

Event Type  Injury  

Manufacturer Narrative

Based on the information provided no conclusion can be determined at this time.A review of the manufacturing records was performed and found that the lot was manufactured to specification.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

It has been reported that in (b)(6) 2013 the patient was implanted with a bard ventralex st hernia patch for ventral hernia repair.Following implant the patient began to experience pain.As reported the patient's surgeon discovered that the "mesh has tore away from the abdomen and was curled up into a ball." on (b)(6) 2016 the patient underwent explant of the mesh.It is reported that the patient has nerve pain and a deformity caused by scar tissue in the area where the patch used to be, but the pain is no longer intense as it was prior to removing the mesh.

Manufacturer Narrative

Addendum to the previous information.This supplemental emdr is being sent to provide the specific implant and explant dates of the ventralex st mesh device.It was originally alleged that the patient experienced detachment of device and material deformation, however, the information provided from the patient's attorney did not mention any type of mesh deformation or detachment.The information provided does allege the patient experienced hernia recurrence, recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.

Event Description

The following was reported to davol by the patient's attorney: on (b)(6) 2013 - the patient underwent surgery for repair of a ventral hernia, a ventralex st was implanted to repair the hernia defect.On (b)(6) 2016 - the patient underwent an additional surgery to repair recurrent hernia after the ventralex st allegedly failed and to remove the ventralex st.The attorney alleges the patient subsequently endured additional surgeries to treat mesh related complications, has suffered and will continue to suffer physical pain and was injured severely and permanently.

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2013 - the patient underwent surgery for repair of a ventral hernia, a ventralex st was implanted to repair the hernia defect.(b)(6) 2016 - the patient underwent an additional surgery to repair recurrent hernia after the ventralex st allegedly failed and to remove the ventralex st.The attorney alleges the patient subsequently endured additional surgeries to treat mesh related complications, has suffered and will continue to suffer physical pain and was injured severely and permanently.Addendum per additional information provided: (b)(6) 2013 - patient was diagnosed with ventral hernia and underwent open repair with ventralex st mesh.Per the operative notes, "identifying 2 small ventral hernias that were incarcerated with preperitoneal fat.A ventralex st circular prosthetic mesh was laid beneath the fascia and tacked.A good secure underlaid mesh patch was achieved".(b)(6) 2013 - patient frequently visited hospital due to abdominal pain.30-mar-2016 - patient was diagnosed with abdominal pain, recurrent incisional ventral hernia and underwent mesh removal.Per the operative notes, "the hernia was identified, excised and removed.The previously placed mesh had slipped inferiorly.The mesh was carefully dissected and completely removed.The umbilical hernia recurrent incisional hernia were closed using sutures".Attorney alleges that the patient had mesh migration, pain, hernia recurrence, deformity of abdomen and emotional injuries.

Manufacturer Narrative

Based on the information provided no conclusion can be determined at this time.A review of the manufacturing records was performed and found that the lot was manufactured to specification.If additional information is obtained, a supplemental mdr will be submitted.Addendum 1: this is an addendum to the initial report to document a correction to h6.Addendum 2: addendum to the previous information.This supplemental emdr is being sent to provide the specific implant and explant dates of the ventralex st mesh device.It was originally alleged that the patient experienced detachment of device and material deformation, however, the information provided from the patient's attorney did not mention any type of mesh deformation or detachment.The information provided does allege the patient experienced hernia recurrence, recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.Addendum 3: this supplemental mdr is submitted to document additional information provided.Based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per medical record review, post implant of ventralex st, patient was diagnosed with abdominal pain, hernia recurrence thereby underwent mesh removal.Per op notes ¿the previously placed mesh had slipped inferiorly¿.Note: section a through f - the information provided by bd 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 bd.H3 other text : not returned.

• 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
• 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: 6173210
• MDR Text Key: 62327405
• Report Number: 1213643-2016-00576
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031496
• UDI-Public: (01)00801741031496
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2015
• Device Catalogue Number: 5950009
• Device Lot Number: HUXD1375
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2013
• 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): Disability; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 70 KG