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

Catalog Number	0010215
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Obstruction/Occlusion (2422)
Date of Event	06/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported per clinical trial (b)(6): on (b)(6) 2016: the subject patient underwent primary laparoscopic midline umbilical hernia repair procedure, during which a bard/davol ventrio hernia patch was implanted.Skin closure was achieved with staples.The patient was discharged on (b)(6) 2016.On (b)(6) 2018: the patient was diagnosed with small bowel obstruction secondary to bowel adhesion of the mesh and underwent surgical procedure for mesh removal.The patient was discharged to home on (b)(6) 2018.Per the study clinician, the reported adverse event has been assessed as severe in severity, definitely related to the study device and definitely related to the index procedure.The outcome for this ae is reported as recovered/resolved.
Additional Manufacturer Narrative
As reported, about 1.5 year post-implant of bard/davol ventrio mesh, the patient was diagnosed with small bowel obstruction, bowel adhesion and underwent surgical intervention for mesh explant.As reported, the ae has resolved.The clinician has assessed the patient¿s postoperative course as being ¿definitely¿ related to the study device and definitely related to the index procedure, however, based on the information provided, no conclusion can be made.Adhesion is a known inherent risk of surgery.The adverse reactions section of the instructions-for-use supplied with the device lists adhesion as a possible complication.To date, this is the only reported complaint for this manufacturing lot.Not returned - mesh explanted.

• 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
• 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 ; 8005566756
• MDR Report Key: 14490184
• Report Number: 1213643-2022-00319
• Device Sequence Number: 4809751
• Product Code: FTL
• UDI-Device Identifier: 00801741016424
• UDI-Public: (01)00801741016424
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2022

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: 10/28/2017
• Device Catalogue Number: 0010215
• Device Lot Number: HUYJ0158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 96 KG