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

Catalog Number	0010218
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Disability (2371)
Date of Event	12/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol ventrio (device #1) device may have caused or contributed to the reported event.The attorney alleges the patient underwent an additional surgery for recurrent hernia, small bowel herniation, adhesions and to remove the infected device.The mesh had bunched up in several places.Recurrence is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication.Regarding 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." a review of the manufacturing records was performed and found that the lot was manufactured to specification.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol ventrio (device #1).An additional emdr was submitted to represent the bard/davol ventrio st (device #2).Note: not returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2011: the patient underwent repair of an incisional hernia.A bard/davol ventrio (device #1) was implanted in the patient during this repair.On (b)(6) 2016: the patient underwent surgery to partially explant the infected hernia mesh and repair a large recurrent hernia.A bard/davol ventrio st (device #2) was implanted in the patient during this repair.During the surgery the physician encountered a ¿large recurrent ventral hernia.¿ the physician noted that ¿there was a small bowel herniated into the hernia sac and this was adhered to a border of mesh.¿ and ¿the bowel was too adhered to the mesh and a small island of mesh was resected and left with the bowel.The mesh had bunched up in several places¿¿ the physician removed as much of the failed ventrio (device #1) as he could safely remove.On (b)(6) 2017 to (b)(6) 2047: the patient was admitted to the hospital.During this extended hospitalization, the patient underwent numerous surgical procedures to treat the patient's chronic abdominal infections and removal of the infected ventrio st (device #2).During the various procedures that were required to remove the infected mesh the physician noted ¿abdominal wall abscess¿, ¿draining sinus¿, ¿cellulitis¿, ¿ptfe, which was essentially disintegrated¿, ¿infected abdominal wall mesh¿, ¿disintegrating ptfe in the field¿, ¿bowel was largely frozen in place¿, ¿folded ptfe¿, ¿extensive adhesiolysis¿, and ¿fistula¿.The patient continues to experience complications related to the mesh.The patient will likely require additional surgeries to repair the damage from the mesh products.The mesh implanted in the patient failed to reasonably perform as intended.The products caused serious injury and had to be surgically removed via invasive surgery, necessitating additional invasive surgery to repair the hernia that the products had initially been implanted to treat.The patient has been injured.The patient has sustained severe and permanent pain, suffering, anxiety, depression, disability, and impairment.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2011: the patient underwent repair of an incisional hernia.A bard/davol ventrio (device #1) was implanted in the patient during this repair.(b)(6) 2016: the patient underwent surgery to partially explant the infected hernia mesh and repair a large recurrent hernia.A bard/davol ventrio st (device #2) was implanted in the patient during this repair.During the surgery the physician encountered a ¿large recurrent ventral hernia.¿ the physician noted that ¿there was a small bowel herniated into the hernia sac and this was adhesed to a border of mesh.¿ and ¿the bowel was too adhesed to the mesh and a small island of mesh was resected and left with the bowel.The mesh had bunched up in several places¿¿ the physician removed as much of the failed ventrio (device #1) as he could safely remove.(b)(6) 2017 to (b)(6) 2047: the patient was admitted to the hospital.During this extended hospitalization, the patient underwent numerous surgical procedures to treat the patient's chronic abdominal infections and removal of the infected ventrio st (device #2).During the various procedures that were required to remove the infected mesh the physician noted ¿abdominal wall abscess¿, ¿draining sinus¿, ¿cellulitis¿, ¿ptfe, which was essentially disintegrated¿, ¿infected abdominal wall mesh¿, ¿disintegrating ptfe in the field¿, ¿bowel was largely frozen in place¿, ¿folded ptfe¿, ¿extensive adhesiolysis¿, and ¿fistula¿.The patient continues to experience complications related to the mesh.The patient will likely require additional surgeries to repair the damage from the mesh products.The mesh implanted in the patient failed to reasonably perform as intended.The products caused serious injury and had to be surgically removed via invasive surgery, necessitating additional invasive surgery to repair the hernia that the products had initially been implanted to treat.The patient has been injured.The patient has sustained severe and permanent pain, suffering, anxiety, depression, disability, and impairment.
Additional Manufacturer Narrative
This emdr corrects the fields lot expiration date and manufacturing date.

• Brand Name: VENTRIO
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8097278
• Report Number: 1213643-2018-04139
• Device Sequence Number: 2792382
• Product Code: FTL
• UDI-Device Identifier: 00801741016455
• UDI-Public: (01)00801741016455
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019

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: 08/28/2011
• Device Catalogue Number: 0010218
• Device Lot Number: HUUB1454
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability