MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRIO MESH; SURGICAL MESH

Catalog Number	0010217
Medical Device Problem Codes	Material Separation (1562); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930)
Date of Event	05/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusion can be made.As reported, approximately 10 years post-implant of the ventrio mesh, the patient experienced abdominal abscess and infection, and underwent surgical intervention with partial explant of the mesh.The surgeon notes that the mesh had ¿started separating.¿ review of manufacturing records indicate product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in may, 2011.Regarding infection the warnings section of instructions for use (ifu) supplied with this device states: "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." note the reported date of implant is prior to the release of the reported product code/lot number for distribution.If/when additional information is received a supplemental mdr will be submitted.Not returned.
Event or Problem Description
On (b)(6) 2011- the patient underwent incisional hernia repair with implant of a bard/davol x-large ventrio mesh.In (b)(6) 2021 - the patient returned two weeks before (b)(6) 2021 with an abdominal abscess.On (b)(6) 2021 - the surgeon performed an exploratory laparotomy and discovered that the mesh had separated from the layers.As reported, "the surgeon stated that the mesh had started separating and he thinks this caused an infection." as reported, the surgeon felt that mesh was possibly defective and should not have separated.The remnant of the mesh was sent to pathology.As reported, the patient is doing well and was discharged to home.

• Brand Name: VENTRIO MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 11966894
• Report Number: 1213643-2021-20142
• Device Sequence Number: 14556528
• 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: 2011
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2021

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: 05/28/2014
• Device Catalogue Number: 0010217
• Device Lot Number: HUVE0919
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/09/2021
• 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