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

Model Number 5950007

Device Problems Defective Device (2588); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Pain (1994); Hernia (2240); Disability (2371)

Event Date 05/19/2017

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 no medical records have been provided.Based on the information provided, 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 mdr will be submitted.Not returned to manufacturer.

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2015 - the patient underwent surgery for repair of an umbilical hernia, a ventralex st mesh was implanted to repair the hernia defect.(b)(6) 2015 - the patient underwent an additional surgery to repair the hernia defect and remove it.At that time a non-bard davol mesh was implanted and the previous ventralex mesh was partially excised.(b)(6) 2017 - the patient underwent an additional surgery to repair the hernia defect and remove it.At that time, both prior meshes were removed , along with a partial resection of the abdominal wall.New biologic mesh was placed.The attorney alleges the patient has suffered and will continue to suffer pain, and was injured severely and permanently.

Manufacturer Narrative

Addendum to the previous information.This supplemental emdr is being sent to correct the expiration date for the ventralex st mesh.A review of the manufacturing records was conducted which found no anomalies during the manufacturing process of the device.With the current information available no definitive conclusion can be made.If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.To date no medical records have been provided.Based on the information provided, 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 mdr will be submitted.Addendum #1: addendum to the previous information.This supplemental emdr is being sent to correct the expiration date for the ventralex st mesh.A review of the manufacturing records was conducted which found no anomalies during the manufacturing process of the device.With the current information available no definitive conclusion can be made.If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.Addendum #2: h11: this supplemental emdr is submitted to document additional information provided and to correct manufacturing date.Based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per the medical records review, about 1 year 9 months post implant of ventralex st mesh, patient had abdominal pain, hernia recurrence thereby underwent repair with mesh removal.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.

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2015 - the patient underwent surgery for repair of an umbilical hernia, a ventralex st mesh was implanted to repair the hernia defect.(b)(6) 2015 - the patient underwent an additional surgery to repair the hernia defect and remove it.At that time a non-bard davol mesh was implanted and the previous ventralex mesh was partially excised.(b)(6) 2017 - the patient underwent an additional surgery to repair the hernia defect and remove it.At that time, both prior meshes were removed , along with a partial resection of the abdominal wall.New biologic mesh was placed.The attorney alleges the patient has suffered and will continue to suffer pain, and was injured severely and permanently.Addendum per additional information provided: (b)(6) 2015 - patient was diagnosed with umbilical hernia and underwent open repair with implant of ventralex st.Per operative notes, "hernia defect with preperitoneal fat extruding was noted and reduced.The ventralex st mesh (device #1) was placed into the subfascial space".(b)(6) 2015 - patient was diagnosed with ventral hernia and underwent laparoscopic repair with implant of synthetic mesh.Per operative notes, "there were adhesions at the umbilicus that were taken down revealing a defect.A synthetic mesh was inserted and laid under the defect.Multiple absorbatacks were used to secure the mesh." (note: no mention/visualization of ventralex st during the procedure).(b)(6) 2017 - patient was diagnosed with pain at prior incisional hernia repair site and underwent removal of previous meshes and implanted with phasix mesh.Per operative notes, "a mass consistent with a previously placed mesh along with a hernia sac was dissected out and excised (device #1) from umbilicus.Next, underlying mesh that has been placed during laparoscopic repair was also removed.A phasix mesh (device #2) was placed and sutured." attorney alleges that the patient had adhesions, infection, pain and hernia recurrence.

• 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: 7140314
• MDR Text Key: 95590644
• Report Number: 1213643-2017-01094
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031472
• UDI-Public: (01)00801741031472
• 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
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2016
• Device Model Number: 5950007
• Device Catalogue Number: 5950007
• Device Lot Number: HUYG1070
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 04/25/2018; 08/22/2023
• Supplement Dates FDA Received: 04/26/2018; 09/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2014
• 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: 52 YR
• Patient Sex: Female