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

Model Number	0010219
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Cellulitis (1768); Unspecified Infection (1930); Pain (1994); Disability (2371)
Date of Event	09/19/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event.Based on the information provided it is alleged the patient experienced infection, the warning section of the instructions-for-use states "if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis.¿ 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 or Problem Description
The following was reported to davol by the patient's attorney: on (b)(6) 2013 - the patient underwent surgery for repair of an incisional ventral hernia, a ventrio hernia mesh was implanted to repair the hernia defect.On (b)(6) 2013 - the patient underwent an additional surgery to remove infected mesh.The attorney alleges the patient has suffered and will continue to suffer pain and was injured severely and permanently.
Additional Manufacturer Narrative
Addendum to the previous information.This supplemental emdr is being sent to correct the date of event.A review of the manufacturing records was conducted which found that the device provided was manufactured to specification.With the current information available, no definitive conclusion can be made.If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.
Additional Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event.Based on the information provided it is alleged the patient experienced infection, the warning section of the instructions-for-use states "if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis.¿ if additional event and/or evaluation information is obtained, a follow up mdr will be submitted.Addendum #1: addendum to the previous information.This supplemental emdr is being sent to correct the date of event.A review of the manufacturing records was conducted which found that the device provided was manufactured to specification.With the current information available, no definitive conclusion can be made.If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.Addendum #2: 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 conclusion can be made.Per medical records review, post implant of ventrio mesh, patient was diagnosed with infection, cellulitis and adhesions thereby underwent repair with mesh removal.The adverse reaction section of the instructions-for-use, supplied with the device identifies adhesions as a possible complication.This supplemental emdr represents ventrio mesh (device #1).Additional emdr's were submitted to represent phasix meshes (device #2 & #3).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 or Problem Description
The following was reported to davol by the patient's attorney: on (b)(6) 2013 - the patient underwent surgery for repair of an incisional ventral hernia, a ventrio hernia mesh was implanted to repair the hernia defect.On (b)(6) 2013 - the patient underwent an additional surgery to remove infected mesh.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) 2013 - patient was diagnosed with recurrent incarcerated incisional ventral hernia thereby underwent open repair with the implant of ventrio mesh (device #1).Per operative notes, "the hernia sac was identified and excised.A ventrio mesh (device #1) was positioned into the peritoneal cavity and tacked to the anterior abdominal cavity." on(b)(6) 2013 - patient was diagnosed with abdominal wall infection, cellulitis and infected mesh thereby underwent exploratory laparotomy with the removal of mesh (device #1).Per operative notes, "incision was carried down to the level of the mesh (device #1) and noted that there was a copious amount of fluid around the mesh and suctioned out.Lysis of adhesions was performed and there was noted some adherent small bowel intrabdominal content.Once, this was done the mesh (device #1) was removed." on (b)(6) 2018 - patient was diagnosed with ventral hernia thereby underwent open repair with the implant of phasix meshes (device #2 & device #3).Per operative notes, ¿hernia sac was resected and a phasix mesh (device #2) was trimmed, placed and sutured to the rectus sheath.Another phasix mesh (device #3) was trimmed, placed and sutured to the external oblique of aponeurosis circumferentially.¿ on (b)(6) 2018 - patient was diagnosed with abdominal post operative wound infection thereby underwent debridement of abdominal wound and wound vac placement.Per operative notes, ¿laparotomy incision had to be reopened to allow debridement.On the left side, there was extensive fat necrosis of the deep fat.There was mesh (device #3) at the base of the wound, this was a superficial mesh placed as a reinforcement.The strength layer of the mesh (device #2) in the retrorectus position was not exposed.The midline fascial closure was healing and not interrupted.All nonviable or infected tissue was removed.¿ on (b)(6) 2018 and (b)(6) 2018 - patient underwent repair for abdominal post operative wound infection and wound dehiscence.(note: there was no mention/visualization of meshes).Attorney alleged that the patient had bowel removal, infection, pain and emotional injuries.It is also alleged that patient underwent removal of mesh, abdominal wall reconstruction, debridement, wound vac placement and wound closure.

• Brand Name: VENTRIO MESH
• Common Device Name: 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: 7153869
• Report Number: 1213643-2017-01135
• Device Sequence Number: 18850244
• Product Code: FTL
• UDI-Device Identifier: 00801741016462
• UDI-Public: (01)00801741016462
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2015
• Device Model Number: 0010219
• Device Catalogue Number: 0010219
• Device Lot Number: HUWL1152
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 05/17/2018; 11/30/2023
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 05/17/2018; 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 108 KG