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

Model Number 5950009

Device Problems Defective Device (2588); Material Deformation (2976); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Pain (1994); Hernia (2240); Disability (2371); Fibrosis (3167)

Event Date 07/10/2015

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.The information provided alleges that the, "patient underwent an additional surgery to repair the hernia defect and remove it." medical records were not provided and the description does not clearly define what "remove it" is referring to (example possible mesh explant, partial explant, or removal/repair of the hernia defect itself without explant of previously placed mesh).As such at this time, we have not identified this as reported device explant.It is unclear at this time if the hernia defect repaired post implant of the mesh was a recurrence of the original hernia defect or a new hernia defect, however, 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.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 to manufacturer.

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 bard/davol ventralex st mesh was implanted to repair the hernia defect.On (b)(6) 2015 - the patient underwent an additional surgery to repair the hernia defect and remove it.The attorney alleges the patient has suffered and will continue to suffer 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 bard/davol 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.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) 2013 - patient was diagnosed with ventral hernia thereby underwent open repair with the implant of ventralex st mesh (device #1).Per operative notes, ¿the hernia defect and adhesions involving the hernia sac were taken down.A large piece of ventralex st (device #1) was placed intraperitoneally with sutures.¿ (b)(6) 2015 - patient was diagnosed with pain, recurrent incisional hernia thereby underwent laparoscopic repair with the removal of old mesh (device #1).Per operative notes, ¿there were omental adhesions involving old mesh and these were taken down completely.The old mesh (device #1) had contracted and was not covering the defect just above the umbilicus.The old mesh was dissected away from the abdominal wall and detached.A piece of ventralight st mesh (device #2) was placed and the edges of the mesh was then tacked to the abdominal wall with sutures.The coated side was down, and the rough side was up.¿ attorney alleges that the patient had adhesions, mesh shrinkage, pain and hernia recurrence.

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.The information provided alleges that the, "patient underwent an additional surgery to repair the hernia defect and remove it." medical records were not provided and the description does not clearly define what "remove it" is referring to (example possible mesh explant, partial explant, or removal/repair of the hernia defect itself without explant of previously placed mesh).As such at this time, we have not identified this as reported device explant.It is unclear at this time if the hernia defect repaired post implant of the mesh was a recurrence of the original hernia defect or a new hernia defect, however, 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: this supplemental emdr 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 records review, about 1 year 8 months post implant of ventralex st mesh, patient was diagnosed with hernia recurrence, adhesions, fibrosis, mesh deformation, abdominal pain thereby underwent repair with mesh removal.Per op notes, " the old mesh had contracted and was not covering the defect just above the umbilicus." the adverse reaction section of the instructions-for-use (ifu) supplied with the device list adhesions as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.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: 7153038
• MDR Text Key: 96005129
• Report Number: 1213643-2017-01131
• 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
• Report Date: 01/12/2024

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: 12/28/2014
• Device Model Number: 5950009
• Device Catalogue Number: 5950009
• Device Lot Number: HUWL0401
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 12/19/2023
• Supplement Dates FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2012
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 65 KG