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

Catalog Number	5950040
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	01/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-jan-2017) is considered to be a best estimate.This emdr represents the bard ventrio st (device 3).Additional supplemental emdrs were submitted to represent the bard flat mesh (device 1) and bard mesh - composix (device 2).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.
Event or Problem Description
Per information provided: ni-ni-ni ¿ patient had a ventral hernia thereby underwent repair with bard flat mesh (device 1).(note: there is no operative notes provided for this procedure in ppf and medical records).(b)(6) 1997 ¿ patient was diagnosed with recurrent incarcerated ventral hernia thereby underwent open repair with sutures.Per operative notes, ¿the hernia at the edge of the previous mesh (device 1) was identified.Multiple adhesions of small bowel to anterior abdominal wall was lysed.The hernia defect between fascia and mesh (device 1) was noted.The hernia defect with mesh (device 1) was closed with sutures.¿(note: there is no implant of any mesh during this procedure).(b)(6) 2000 ¿ patient was diagnosed with large ventral hernia, abdominal pain and partial small bowel obstruction thereby underwent open repair with implant of composix mesh (device 2).Per operative notes, ¿a large ventral hernia sac was dissected, and area of obstruction was encountered with extensive scar tissue forming adhesion to the peritoneum of hernia sac.Adhesions were lysed bowel was relieved and composix mesh (device 2) was placed and sutured.¿ (b)(6) 2000 ¿ patient had abdominal wound exploration and removal of necrotic tissue.(note: the mesh (device 1) was seen during this procedure).(b)(6) 2001¿ patient was diagnosed with recurrent incarcerated ventral hernia thereby underwent open repair with partial removal of bard flat mesh (device 1) and composix mesh (device 2) and debridement of necrotic sac.Per operative notes, ¿in the midline, the hernia sac was necrotic.All the necrotic hernia sac, dense adhesions exposed parts of mesh (device 1 and 2) were excised.The large defect was closed primarily with sutures.(b)(6) 2002 ¿ patient was diagnosed with persistent sinus tract abdominal wall thereby underwent open repair with removal of retained mesh (device 1 and 2).Per operative notes, ¿sinus tract was excised circumferentially.The prolene sutures with retained mesh (device 1 and 2) was excised and wound was closed with sutures.¿ (b)(6) 2008 - patient was diagnosed with ventral wall hernia thereby underwent open repair.Per operative notes, ¿multiple adhesions were lysed.The hernia defect and sac on left midline of abdominal wall was dissected.The circular defect was closed with sutures.¿ (b)(6) 2008 - patient was diagnosed with ventral hernia thereby underwent open repair with implant of two biological mesh.Per operative notes, ¿the hernia defect was closed, and a biological mesh was used for closure of abdominal wall and large biological mesh as an additional support and sutured.¿ (b)(6) 2008 - patient was diagnosed with wound infection thereby underwent open repair with dehiscence of wound closure and removal of biological mesh.Per operative notes, ¿the fat necrosis and biological mesh was excised and closed with sutures.¿ (b)(6) 2012 ¿ patient had triple recurrent ventral incisional hernia, adhesions thereby underwent repair with biological mesh.(b)(6) 2013 ¿ patient had recurrent ventral hernia thereby underwent repair with biological mesh.(b)(6) 2017 ¿ patient was diagnosed with complex incarcerated multiple ventral recurrent incisional hernia thereby underwent open repair with implant of ventrio st mesh (device 3).Per operative notes, ¿in the epigastrium, recurrent hernia in the prior mesh reconstruction was noted.Adhesions and hernia sac was removed and ventrio st mesh (device 3) was placed and sutured.¿ (b)(6) 2019 ¿ patient was diagnosed with incarcerated ventral recurrent hernia thereby underwent open repair with implant of ventrio st mesh (device 4).Per operative notes, ¿multiple adhesions involving small bowel, omentum, abdominal wall were lysed.Multiple recurrent ventral incisional hernias with sac was noted and excised.A large ventrio st mesh (device 4) was placed over the defect and secured with sutures.¿.

• 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: 23024803
• Report Number: 1213643-2025-00826
• Device Sequence Number: 13140202
• Product Code: FTL
• UDI-Device Identifier: 00801741031533
• UDI-Public: (01)00801741031533(17)190228(10)HUBN2416
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2025

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: 02/28/2019
• Device Catalogue Number: 5950040
• Device Lot Number: HUBN2416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2017
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 118 KG