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

Catalog Number	0010217
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930); Disability (2371)
Date of Event	07/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol ventro device may have caused or contributed to the reported event.The attorney alleges the patient underwent an additional surgery to remove the infected device.Another surgery was required to repair an intestinal fistula.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." fistula formation is a known inherent risk of surgery and is listed in the instructions-for-use as a possible adverse reaction.A manufacturing review that included review of sterility 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.Note: not returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2010: the patient underwent repair of a ventral hernia.A bard/davol ventrio was implanted in the patient during this repair.On (b)(6) 2017: the patient underwent surgery to explant the infected ventrio mesh.During the surgery the physician noted that "the mesh appeared to be involved with an infected abscess within the abdomen." on (b)(6) 2017: the patient underwent a repair of an intestinal fistula secondary to the mesh infection.The physician noted that the patient would require additional surgery to implant another mesh device.The patient continues to experience complications related to the mesh and will likely require additional surgeries to repair the damage from the mesh.The mesh implanted in the patient failed to reasonably perform as intended.The mesh caused serious injury and had to be surgically removed via invasive surgery, and necessitated additional invasive surgery to repair the hernia that the mesh was initially implanted to treat.The patient has been injured, sustained severe and permanent pain, suffering, anxiety depression, disability, and impairment.

• 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: 8091568
• Report Number: 1213643-2018-04097
• Device Sequence Number: 1407224
• Product Code: FTL
• UDI-Device Identifier: 00801741016448
• UDI-Public: (01)00801741016448
• 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: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2018

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: 07/28/2011
• Device Catalogue Number: 0010217
• Device Lot Number: HUUA0814
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 11/20/2018
• 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: Required Intervention; Disability