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

Catalog Number 0010303

Device Problems Defective Component (2292); Defective Device (2588); Patient-Device Incompatibility (2682); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Hernia (2240); Injury (2348); Disability (2371)

Event Date 02/07/2017

Event Type  Injury  

Manufacturer Narrative

To date, limited information has been provided.Based on the limited information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.Hernia recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the ifu as a possible complication.If additional information is obtained, a supplemental mdr will be submitted.Not returned.

Event Description

It is alleged by the patients attorney that on (b)(6) 2010, the patient underwent surgery for repair of an incisional ventral hernia.As reported, a bard/davol ventralex hernia patch mesh, (b)(4), lot number huug2256 was implanted to repair the hernia defect.It is alleged that on (b)(6) 2017, the patient underwent an additional surgery to repair the hernia defect and remove the ventralex hernia patch because the mesh was defective, failed and "caused damage to her internal organs." as alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective ventralex hernia patch.

Event Description

It is alleged by the patients attorney that on (b)(6) 2010, the patient underwent surgery for repair of an incisional ventral hernia.As reported, a bard/davol ventralex hernia patch mesh, reference number 0010303, lot number huug2256 was implanted to repair the hernia defect.It is alleged that on (b)(6) 2017, the patient underwent an additional surgery to repair the hernia defect and remove the ventralex hernia patch because the mesh was defective, failed and "caused damage to her internal organs." as alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective ventralex hernia patch.Addendum per additional information provided: (b)(6) 2010 - patient was diagnosed with incisional ventral hernia thereby underwent open repair with the implant of ventralex hernia patch.Per operative notes, ¿the hernia sac, some extruded preperitoneal fat were resected and the herniated omentum was reduced.A ventralex patch was placed into the peritoneal cavity and sutured.¿.Between (b)(6) 2014 to (b)(6) 2017 - patient had hospital visit for left plank pain, left ureteral calculus and recurrent incisional flank hernia.(b)(6) 2017 - patient was diagnosed with recurrent incisional flank hernia thereby underwent open repair with explant of ventralex hernia patch.Per operative notes, ¿the old mesh was adherent to a loop of bowel, which was incarcerated in a fold of mesh.This was dissected off sharply and the remainder of the mesh was excised.The hernia defect was dissected, a synthetic mesh was placed and sutured.¿.Attorney alleges that patient had adhesion, hernia recurrence, nerve damage, mesh migration and pain.It also alleged that the mesh had folded over.

Manufacturer Narrative

To date, limited information has been provided.Based on the limited information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.Hernia recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the ifu as a possible complication.If additional information is obtained, a supplemental mdr will be submitted.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the date of event and manufacturing date.Based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per medical records review, about 6 years 1 month post implant of ventralex hernia patch, patient was diagnosed with mesh deformation, adhesion and hernia recurrence thereby underwent repair with explant of mesh.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.

• 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: 7143363
• MDR Text Key: 95658165
• Report Number: 1213643-2017-01105
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016486
• UDI-Public: (01)00801741016486
• 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: 01/04/2024

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: 08/28/2015
• Device Catalogue Number: 0010303
• Device Lot Number: HUUG2256
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 12/14/2023
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2010
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 83 KG