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

Catalog Number 0010302

Device Problems Defective Device (2588); Folded (2630); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240); Disability (2371)

Event Date 04/15/2014

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.It is alleged the patient experienced pain, recurrence and adhesions.Adhesions and recurrence are both listed as know possible adverse reactions in the instructions-for-use.Currently with the information provided, it is unclear if the ventralex mesh was removed during the (b)(6) 2014 procedure as it was reported that the patient underwent additional surgery "to repair the hernia defect and remove it." it is unclear at this time what the "it" is referring to whether it was the previously implant ventralex mesh or the actual hernia itself.A manufacturing review was performed which found no anomalies during the manufacturing process of the device.With the current information available, no definitive conclusion can be made as to the extent that the device may have caused or contributed to any post op complications.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: (b)(6) 2005 - the patient underwent surgery for repair of an incisional hernia.A ventralex hernia patch was implanted to repair the hernia defect.On (b)(6) 2014 -the patient underwent an additional surgery to repair the hernia defect and remove it.As a result of the ventralex failure, the mesh folded while inside her body causing pain, hernia recurrence, adhesions and scarring.Patient was severely and permanently injured.The attorney alleges the patient experienced pain, hernia recurrence, adhesions, scarring, disability and additional surgical procedure.

Event Description

Per legal complaint (b)(4).It is alleged by the patient's attorney that on (b)(6) 2005 the patient underwent repair of an incisional hernia.A ventralex hernia patch mesh, reference number 0010302 and lot number 43hpd478 was implanted to repair the hernia defect.As reported, about 9 years later on (b)(6) 2014 the patient underwent an additional surgery to repair the hernia defect and remove it.As a result of the ventralex failure, the mesh folded while inside her body causing pain, hernia recurrence, adhesions and scarring.It is alleged by the patient's attorney that the patient was injured severely and permanently due to the ventralex mesh being defective.Addendum per medical records: (b)(6) 2005 - patient underwent incisional hernia repair with the implant of bard/davol ventralex mesh.Per the operative report , the hernia sac was completely dissected off the umbilicus, a finger sweep was performed and there were small adhesions that were freed up.The defect was fairly small, approximately 2.5 cm x 2.5 cm x 2 cm in size.A ventralex medium patch was then placed into the defect and the straps pulled out through the defect securing the marlex part of the mesh up to the abdominal wall, keeping the straps taut as it was elevated.(b)(6) 2014 - patient was diagnosed with sigmoid diverticulitis with stricture and underwent hand-assisted laparoscopic sigmoid colectomy and coloproctostomy with mesh explant.As per operative notes, there were some adhesions of the omentum up to a prior small ventral hernia mesh just below the umbilicus."it did appear that this mesh was no longer functioning as it was quite folded up on itself and the hernia was visible just deep to the mesh.¿ the surgeon then removed adhesions from the upper abdomen and small bowel.¿once the fascia was opened, i did encounter as well the old mesh that was located at the top portion of this incision, and this was completely removed.¿ (b)(6)2015 - patient underwent a laparoscopic incarcerated ventral incisional hernia repair (x2).As reported, the patient had been to the hospital several times for pain.Ct scan was done which showed these defects.As per the operative report, ¿measurements were taken for the appropriate sized mesh and a 15 x 10 cm mesh (bard/davol composix l/p mesh) was obtained.Small incision was made right by the umbilicus and the defects were identified.The hernia sacs were removed in their entirety down to good fascia, the mesh was tacked in 4 quadrants and snugged up nicely against the anterior abdominal wall covering the defect nicely.Tacking device was used to further tack the mesh without difficulty.¿ attorney also alleges that the patient experienced adhesion, bowel/intestinal obstruction, bowel/intestinal removal, infection, mesh migration, mesh shrinkage and pain.

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.It is alleged the patient experienced pain, recurrence and adhesions.Adhesions and recurrence are both listed as know possible adverse reactions in the instructions-for-use.Currently with the information provided, it is unclear if the ventralex mesh was removed during the (b)(6) 2014 procedure as it was reported that the patient underwent additional surgery "to repair the hernia defect and remove it." it is unclear at this time what the "it" is referring to whether it was the previously implant ventralex mesh or the actual hernia itself.A manufacturing review was performed which found no anomalies during the manufacturing process of the device.With the current information available, no definitive conclusion can be made as to the extent that the device may have caused or contributed to any post op complications.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.Addendum: this is an addendum to initial emdr submitted (mdr no: 1213643-2017-00297).This supplemental mdr is submitted to report the patient details (dob, age, weight) and explant procedure details, provided in the patient medical records.Based on the information provided, the initial determination remains the same, no conclusions can be made.The explanted mesh was not returned to the manufacturer for evaluation.No pathology or culture reports of the explanted mesh were included.The instructions-for-use supplied with the device lists adhesions and hernia recurrence as possible complications.Note: section a through f - 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.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: 6560079
• MDR Text Key: 74933719
• Report Number: 1213643-2017-00297
• 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: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2010
• Device Catalogue Number: 0010302
• Device Lot Number: 43HPD478
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2005
• 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: 44 YR
• Patient Sex: Female