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

Catalog Number	5950010
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Death (1802); Fistula (1862); Unspecified Infection (1930); Injury (2348)
Date of Event	07/15/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol ventrio device may have caused or contributed to the reported event.No lot number has been provided therefore a review of the manufacturing records is not possible.Information is limited at this time.Should additional information be provided a supplemental emdr will be submitted.No medical records, autopsy, or death certificate have been provided.Should additional information be provided a supplemental emdr will be submitted.Device evaluated by mfr: not returned.
Event or Problem Description
Attorney alleges the patient underwent surgery for implant of an unspecified bard/davol ventrio patch on (b)(6) 2015.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device(s).As reported, the patient is making a claim for an adverse patient outcome against the bard/davol ventrio patch.As reported, the attorney alleges patient experienced emotional distress,the device was defective and wrongful death.
Event or Problem Description
Attorney alleges the patient underwent surgery for implant of an unspecified bard/davol ventrio patch on (b)(6) 2015.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device(s).As reported, the patient is making a claim for an adverse patient outcome against the bard/davol ventrio patch.As reported, the attorney alleges patient experienced emotional distress,the device was defective and wrongful death.Addendum per additional information provided: on (b)(6) 2015 - patient was diagnosed with umbilical hernia thereby underwent laparoscopic repair with the implant of ventrio st.Per op notes, "patient had a small umbilical hernia defect with a large hernia sac.A ventrio st mesh was placed over the hernia defect." on (b)(6) -2017 - patient was diagnosed with enterocutaneous fistula, intra abdominal adhesions thereby underwent repair with the removal of infected mesh and adhesiolysis, small bowel resection.Per op notes, "the mesh was excised.Multiple loops of intestine were densely adherent to the abscess cavity wall.Lysis of adhesions was undertaken." on (b)(6) 2019 - patient passed away.Per the death certificate, the cause of patient death was listed as ¿septic shock, aspiration pneumonia, b-cell lymphoma.¿.
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol ventrio device may have caused or contributed to the reported event.No lot number has been provided therefore a review of the manufacturing records is not possible.Information is limited at this time.Should additional information be provided a supplemental emdr will be submitted.No medical records, autopsy, or death certificate have been provided.Should additional information be provided a supplemental emdr will be submitted.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the implant date, product name and 510k number.Based on the information provided, the patient had fistula, infection, adhesions, abscess and wrongful death.Patient death certificate was provided in the medical records received and the cause of death was ¿septic shock, aspiration pneumonia, b-cell lymphoma¿.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.Updated fields: a2, b2 (date of death), b3, b4, b5, b7, d4 (product catalog no., udi no.), g1, g3, g6, h2, h6, h10, h11.Corrected fields: d1 (brand name), d.6a (date of implant), g4 (pma/510(k)).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.H3 other text : not returned.

• 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: 8836824
• Report Number: 1213643-2019-06390
• Device Sequence Number: 2390228
• Product Code: FTL
• UDI-Device Identifier: 00801741031502
• UDI-Public: (01)00801741031502
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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 Catalogue Number: 5950010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 07/09/2025
• 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; Death
• Patient Age: 79 YR
• Patient Sex: Male