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

Catalog Number	0010211
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	09/21/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6)2002 - patient was diagnosed with left indirect inguinal hernia thereby underwent open hernia repair with the implant of perfix plug (device #1).Per operative notes, "a large indirect hernia identified and was dissected free.A large plug was secured with sutures.An on-lay patch was placed on the floor of the inguinal canal." (b)(6)2004 - patient was diagnosed with supraumbilical ventral hernia thereby underwent open hernia repair.Per operative notes, "the hernia sac was identified and appears to be large.The hernia sac was freed and excised from the hernia defect.The hernia defect was closed transversely with sutures." (notes: no mesh was implanted.) (b)(6)2006 - patient was diagnosed with recurrent left inguinal hernia thereby underwent open hernia repair with the removal of perfix plug (device #1) and implant of synthetic mesh.Per operative notes, "the external oblique was dissected from the mass, the mesh (device #1) was balled up and was excised.The defect in the floor of the groin was noted.The synthetic mesh was placed underlay and sutured.The overlay was tacked to the pubis." (b)(6)2010 - patient was diagnosed with multifenustrated ventral incisional hernia thereby underwent open hernia repair wit the implant of ventrio mesh (device #2).Per operative notes, "a fairly large hernia was seen.The hernia contents were dissected away.The medial end, two small defects were connecting, separating them and dissected.A ventrio patch (device #2) was placed into the preperitoneal space and sutured." (b)(6)2013 - patient was diagnosed with incarcerated ventral hernia thereby underwent open hernia repair with the implant of synthetic mesh.Per operative notes, "the hernia was dissected and the fascial defect was identified.The hernia sac was opened and contained omentum.The distal portion of omentum have been strangulated and ischemic.The defect was adjacent to midline.Another defect on small bowel protruding through another swiss cheese defect.The large amount of adhesions were taken down.The small bowel contents were reduced back.A synthetic mesh was placed on the fascia and sutured." attorney alleged that the patient had adhesions, bowel obstruction, mesh shrinkage, emotional injuries, pain, hernia recurrence, it is also alleged that the mesh had balled up, chronic inflammation, mesh excision and reactive fibrosis.
Additional Manufacturer Narrative
Based on the additional information received, no conclusions can be made.Per medical records review, about 3 years 2 months post implant of ventrio mesh, patient was diagnosed with hernia recurrence, obstruction and adhesions thereby underwent repair with mesh removal.The instructions-for-use supplied with the device lists hernia recurrence and adhesions as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Note, the date of manufacturing (15-jan-2010) is considered to be a best estimate.This emdr represents ventrio mesh (device #2).An additional supplemental emdr was submitted to represent perfix plug (device #1).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.

• 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: 20876057
• Report Number: 1213643-2024-094844
• Device Sequence Number: 8843386
• Product Code: FTL
• UDI-Device Identifier: 00801741016387
• UDI-Public: (01)00801741016387(17)110628(10)HUUA0257
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2024

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: 06/28/2011
• Device Catalogue Number: 0010211
• Device Lot Number: HUUA0257
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2010
• 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: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 122 KG