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

Model Number 0010302

Device Problems Defective Device (2588); Torn Material (3024); Patient Device Interaction Problem (4001); Migration (4003)

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

Event Date 02/08/2013

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, it is alleged the patient underwent additional surgery to repair the hernia defect, 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.In regards to the allegation of tore mesh, without a sample being returned for evaluation, an assessment can not be made in regards to the allegation.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) 2012 - the patient underwent surgery for repair of a ventral hernia, a ventralex hernia mesh was implanted to repair the hernia defect.On (b)(6) 2013 - the patient underwent an additional surgery to repair the hernia defect and remove the ventralex hernia patch because the mesh was allegedly defective, failed, tore and caused damage to her internal organs.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: on (b)(6) 2012, the patient underwent surgery for repair of a ventral hernia, a ventralex hernia mesh was implanted to repair the hernia defect.On (b)(6) 2013, the patient underwent an additional surgery to repair the hernia defect and remove the ventralex hernia patch because the mesh was allegedly defective, failed, tore and caused damage to her internal organs.The attorney alleges the patient has suffered and will continue to suffer pain and was injured severely and permanently.Addendum per additional information provided: on (b)(6) 2012, patient was diagnosed with ventral incisional hernia thereby underwent open repair with implant of ventralex patch (device #1).Per operative notes, "hernia sac contained omentum was identified and reduced.A ventralex patch (device #1) was placed beneath the fascia and sutured." on (b)(6) 2013, patient was diagnosed with recurrent ventral hernia thereby underwent repair with mesh removal (device #1).Per operative notes, "the hernia sac was identified and skeletonized to the level of the fascia.The previously placed mesh had torn from the superior aspect of the fascia creating a recurrent defect and the mesh (device #1) was removed.A synthetic patch was then placed and sutured.On (b)(6) 2014, patient was diagnosed with ventral hernia thereby underwent laparoscopic repair with the implant of composix l/p mesh (device #2).Per operative notes, "hernia defect was determined.A composix l/p mesh (device #2) was laid on the abdominal wall covering the defect and sutured." attorney alleges that patient had hernia recurrence and pain.It is also alleged that the mesh had torn from superior aspect of the fascia.

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, it is alleged the patient underwent additional surgery to repair the hernia defect, 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.In regards to the allegation of tore mesh, without a sample being returned for evaluation, an assessment can not be made in regards to the allegation.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 provided, there is no change to the initial determination, no conclusion can be made.Per the medical records review, about 4 months post implant of ventralex mesh, patient was diagnosed with hernia recurrence and mesh migration thereby underwent repair with the mesh removal.Per op notes "mesh had torn from the superior aspect of the fascia creating a recurrent defect." the instruction for use (ifu) supplied with device list migration as a possible complication.Review of manufacturing records confirms product 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: MESH - VENTRALEX
• 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: 7124608
• MDR Text Key: 95169006
• Report Number: 1213643-2017-01056
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016479
• UDI-Public: (01)00801741016479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021736
• 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: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2017
• Device Model Number: 0010302
• Device Catalogue Number: 0010302
• Device Lot Number: HUWE2297
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2012
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 93 KG