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

Catalog Number	5950070
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	06/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, about 2 years post-implant of the ventrio st mesh, the patient was diagnosed with hernia recurrence.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and definitely related to the index procedure, however, based on the information provided, no conclusion can be made.Hernia recurrence is a known inherent risk of hernia repair surgery.The adverse reactions section of the instructions-for-use, supplied with the device lists hernia recurrence as a possible complication.To date, this is the only reported complaint for this manufacturing lot.Not returned - remains implanted.
Event or Problem Description
Reported per clinical trial (b)(6): on (b)(6) 2016 - subject patient underwent open first-time recurrent midline umbilical hernia repair procedure during which a bard/davol ventrio st mesh was implanted using a non-bard/davol fixation device.The fascia was completely closed using suture and full skin closure was achieved using staples.The patient was discharged from the hospital on the same day.On (b)(6) 2018 - ct scan revealed incisional hernia recurrence of size 1cm x 7.9cm.The patient was not medically cleared for surgery at that time.Per the study clinician, the reported adverse event has been assessed as moderate in severity, possibly related to the study device and definitely related to the index procedure.The outcome for this ae is reported as recovering/resolving.

• Brand Name: VENTRIO ST
• 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: 14488211
• Report Number: 1213643-2022-00301
• Device Sequence Number: 20176691
• Product Code: FTL
• UDI-Device Identifier: 00801741031564
• UDI-Public: (01)00801741031564
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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: 09/28/2016
• Device Catalogue Number: 5950070
• Device Lot Number: HUYJ0844
• 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: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 102 KG