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

Model Number 0010303

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems Adhesion(s) (1695); Bacterial Infection (1735); Inflammation (1932); Pain (1994); Hernia (2240); Disability (2371)

Event Date 02/28/2011

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.Without a lot number a review of the manufacturing records could not be conducted.Based on the limited information available as well as not having a sample returned for evaluation, an assessment could not be made into the allegation of possible detached mesh.In regards to the allegation of possible detached mesh, the warning section of the instructions-for-use states "to ensure strong repair, the prosthesis should be secured with tack or sutures through the polypropylene mesh straps or positioning pocket.Suturing or tacking on the sealed edge of mesh alone is not recommended." 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) 2010 - the patient underwent surgery for repair of a ventral incisional hernia umbilical hernia, a ventralex hernia patch was implanted to repair the hernia defect.On (b)(6) 2011 - the patient underwent an additional surgery to remove the ventralex mesh, during the procedure the physician noted that the ventralex "was hanging loose inside the peritoneal cavity." the attorney alleges the patient has suffered and will continue to suffer pain and was severely and permanently injured.

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.Without a lot number a review of the manufacturing records could not be conducted.Based on the limited information available as well as not having a sample returned for evaluation, an assessment could not be made into the allegation of possible detached mesh.In regards to the allegation of possible detached mesh, the warning section of the instructions-for-use states "to ensure strong repair, the prosthesis should be secured with tack or sutures through the polypropylene mesh straps or positioning pocket.Suturing or tacking on the sealed edge of mesh alone is not recommended." 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 9 months post implant of ventralex mesh, patient was diagnosed with hernia recurrence, infection, mesh migration, adhesions, inflammation, pain thereby underwent repair with mesh removal.Per op notes, "mesh was hanging loose inside the peritoneal cavity." the instructions-for-use supplied with the device lists adhesions, pain, inflammation, migration, infection, hernia recurrence as possible complications.In regard to infection, the warnings section in ifu states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the patch.An unresolved infection may require removal of the mesh." 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: on (b)(6) 2010 - the patient underwent surgery for repair of a ventral incisional hernia umbilical hernia, a ventralex hernia patch was implanted to repair the hernia defect.On (b)(6) 2011 - the patient underwent an additional surgery to remove the ventralex mesh, during the procedure the physician noted that the ventralex "was hanging loose inside the peritoneal cavity." the attorney alleges the patient has suffered and will continue to suffer pain and was severely and permanently injured.Addendum per additional information provided: on (b)(6) 2010 - patient was diagnosed with incarcerated ventral incisional hernia with small bowel obstruction thereby underwent laparoscopic repair with the implant of ventralex mesh (device #1).Per operative notes, ¿there was loop of ileum which stuck out in a very long hernia sac and kinked off.The hernial sac was removed and trimmed back to the fascia.A round ventralex mesh (device #1) was placed behind the fascia anterior to the peritoneum and sutured.¿ on (b)(6) 2010 to (b)(6) 2010 - patient visited hospital for pain, wound infection and antibiotics were provided for infection.On (b)(6) 2011 - patient visited hospital for leaking from abdominal wound, infected mesh and draining sinus tract to the skin in the midportion of surgical scar.On (b)(6) 2011 - patient was diagnosed with infected ventral hernia mesh, recurrent large ventral hernia thereby underwent laparoscopic repair with the removal of mesh (device #1).Per operative notes, ¿mesh was hanging loose inside the peritoneal cavity and the hernia was more inferiorly and toward the left.The adhesions with omentum stuck to the hernia were removed.The mesh was infected which was more in the upper aspect of the previous incision.The mesh (device #1) and hernia sac was excised.¿ on (b)(6) 2014 and (b)(6) 2014 - patient visited hospital for partial small bowel obstruction and incarcerated hernia.On (b)(6) 2014 - patient was diagnosed with incarcerated recurrent incisional hernia in the inferior abdominal wall, incarcerated incisional hernia at the level of the umbilicus thereby underwent laparoscopic and open repair with the implant of sepramesh ip (device #2) and ventralex st mesh (device #3).Per operative notes, ¿just inferior to the umbilicus, hernia sac was dissected.In the anterior abdominal wall, found numerous adhesions and there was a loop of small bowel that went up into the hernia sac.The adhesions were removed from anterior abdominal wall and the hernia defect was brought together with sutures.A piece of sepramesh ip (device #2) was placed with tacker in anterior abdominal wall and sutured.A ventralex st mesh (device #3) was placed in the hernia defect at the umbilicus and sutured.¿ attorney alleges that the patient had abscess, adhesions, bowel obstruction, infection, pain, seroma and hernia recurrence.It was also alleged that the patient had additional surgeries to remove and/or hernia repair.

• 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: 7133453
• MDR Text Key: 95370884
• Report Number: 1213643-2017-01079
• 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: 12/29/2023

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: 03/28/2015
• Device Model Number: 0010303
• Device Catalogue Number: 0010303
• Device Lot Number: HUUB1436
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 37 YR
• Patient Sex: Female
• Patient Weight: 139 KG