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

Catalog Number	5950080
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Bowel Perforation (2668)
Date of Event	04/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2007 ¿ patient was diagnosed with incisional hernia thereby underwent open repair with implant of composix e/x mesh (device 1).Per operative notes, ¿ in the midline, the hernia defect with sac was resected.The adhesions were removed, and composix e/x mesh (device 1) was placed over the hernia defect and secured with sutures circumferentially.¿ on (b)(6) 2008 ¿ patient was diagnosed with recurrent incisional hernia (x2) thereby underwent open repair with implant of composix mesh (device 2) and composix e/x mesh (device 3).Per operative notes, ¿the hernia defects superior and inferior to the prior incisional hernia was noted.Two hernia defect with sacs were reduced.The upper hernia was repaired and composix mesh (device 2) was placed and to the inferior defect, composix e/x mesh (device 3) was placed and secured and irrigated.¿ on (b)(6) 2018 - patient was diagnosed with small bowel obstruction and adhesions to prior mesh thereby underwent open repair with removal of meshes (device 1, 2 and 3) and implant of ventrio st mesh (device 4).Per operative notes, ¿the dense scar tissues were excised.The seroma cavity overlying mesh was drained.Three separate meshes (device 1, 2 and 3) on undersurface of anterior abdominal wall and small bowel plastered to it was noted.Dense adhesions between small bowel in anterior abdominal wall was taken down.The meshes (device 1, 2 and 3) were seen folded over itself and removed.Obstructed portion of bowel was removed and ventrio st mesh (device 4) was placed sutured and tacked in position.¿ on (b)(6) 2018 ¿ patient was diagnosed with perforated ileum and adhesions thereby underwent open repair with removal of prior mesh (device 4).Per operative notes, ¿a perforation in the mid ileum was noted and resected.The previously placed mesh (device 4) and adhesions were removed, and mesenteric defect was closed with sutures.¿ on (b)(6) 2020 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of ventrio mesh (device 5).Per operative notes, ¿an large hernia from sternum to pubis was noted.The hernia sac was reduced; adhesions were lysed and ventrio mesh (device 5) was placed over the defect and sutured circumferentially.¿.
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-sep-2016) is considered to be a best estimate.This mdr represents the ventrio st mesh (device 4).An additional supplemental emdr was submitted to represent the composix e/x mesh (device 1), composix mesh (device 2) and composix e/x mesh (device 3).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 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: 23787957
• Report Number: 1213643-2025-01192
• Device Sequence Number: 10442870
• Product Code: FTL
• UDI-Device Identifier: 00801741031571
• UDI-Public: (01)00801741031571(17)181128(10)HUAW2144
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2025

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: 11/28/2018
• Device Catalogue Number: 5950080
• Device Lot Number: HUAW2144
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2016
• 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