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

Catalog Number	5950030
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fistula (1862); Pain (1994); Hernia (2240); Bowel Perforation (2668); Insufficient Information (4580)
Date of Event	08/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol ventrio on (b)(6) 2011 and ventrio st on (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against the both devices.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol ventrio st (device #2).An additional emdr was submitted to represent the bard/davol ventrio mesh (device #1).Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol ventrio on (b)(6) 2011 and ventrio st on (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against the both devices.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2011 - patient was diagnosed with recurrent 2 incisional hernias thereby underwent open repair with the implant of ventrio mesh (device #1).Per operative notes, ¿hernia sac was dissected.A ventrio mesh (device #1) was placed just above the umbilicus and secure it with suture.¿ (b)(6) 2017 - patient was diagnosed with recurrent ventral incisional hernia, adhesion, scar tissue thereby underwent open repair with implant of the bard ventrio st mesh (device #2).Per operative notes, ¿hernia sac was dissected.The old mesh was folded.Bard ventrio st mesh (device #1) was placed and sutured.Ventrio st mesh (device #2) was anchored at the superior and lateral old ventrio mesh (device #1) to provide positional stability.¿ (b)(6) 2017 ¿ patient was diagnosed with acute recurrent ventral incisional hernia thereby underwent open repair with reinforcement with biological mesh.Per operative notes, ¿old mesh had crumples and rotated.One biological mesh was placed to abdomen area and secure it with suture.¿ (b)(6) 2017 - patient was diagnosed with enterocutaneous fistula, adhesion, 5 incisional hernias thereby underwent laparoscopic repair with lysis of adhesions, ventral hernia repair, small bowel resection and anastomosis.(b)(6) 2018 - patient was diagnosed with infected abdominal wall mesh with subcutaneous fistula, adhesion, thereby underwent open repair with explant of ventrio mesh (device #1) and ventrio st mesh (device #2).Per operative notes, ¿hernia sac was dissected.Intra-abdominal wall omental and bowel adhesions were taken down.Ventrio mesh (device #1) and ventrio st mesh (device #2) was removed from abdominal area.Wound was covered with vac placement.Hernia defect was closed with sutures.¿ (b)(6) 2019 ¿ patient was diagnosed with large ventral incisional hernia, adhesions thereby underwent open repair with implant of phasix mesh (device #3).Per operative notes, ¿hernia sac was dissected out.Small bowels and adhesions were taken down.One phasix mesh (device #3) was placed and secure it with suture.¿ (b)(6) 2020 ¿ patient was diagnosed with chronic abdominal wall sinus thereby underwent open repair with explant of phasix mesh (device #3).Per operative notes, ¿there was small amount of purulent around the old phasix mesh (device #3).Old phasix mesh (device #3) was removed.The wound was irrigated.Fascia was closed with sutures.¿ (b)(6) 2020 ¿ patient was diagnosed with ventral hernia, adhesion thereby underwent laparoscopic repair with implant of ventralight st mesh (device #4).Per operative notes, ¿hernia sac was dissected out.All adhesions were removed.A ventralight st mesh (device #4) was placed and secure it with suture.¿.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol ventrio st (device #2).An additional emdr was submitted to represent the bard/davol ventrio mesh (device #1).Addendum: this supplemental emdr is submitted to document additional information provided.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-oct-2016) is considered to be a best estimate.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 ; 4018258495
• MDR Report Key: 13009894
• Report Number: 1213643-2021-09323
• Device Sequence Number: 4926133
• Product Code: FTL
• UDI-Device Identifier: 00801741031526
• UDI-Public: (01)00801741031526(17)181228(10)HUAX0834
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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: 12/28/2018
• Device Catalogue Number: 5950030
• Device Lot Number: HUAX0834
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2016
• 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; Life Threatening; Disability
• Patient Age: 68 YR
• Patient Sex: Male