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

Catalog Number	5950040
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Necrosis (1971); Pain (1994); Sepsis (2067); Strangulation (2084); Obstruction/Occlusion (2422); Insufficient Information (4580)
Date of Event	01/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol ventrio mesh on (b)(6) 2016.As reported, the patient is making a claim for an adverse patient outcome against the ventrio mesh.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.Should additional information be provided, a supplemental emdr will be submitted.Not returned.
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.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the brand name and 510k number.Based on the information received, post implant of ventrio st mesh, patient had sepsis, strangulation, infection, obstruction, necrosis and hernia recurrence thereby underwent open repair with the removal of ventrio st mesh.Based on the death certificate provided with the medical records, the patient passed away due to cardiopulmonary arrest, septic shock, incarcerated hernia with strangulation and small bowel obstruction on (b)(6) 2021.It is unknown to what extent the device may have caused or contributed to the patient death.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-may-2016) is considered to be a best estimate.Updated fields: a2, a4, b2, b3, b4, b5, b6, b7, d3, d4, d6b, g3, g6, h2, h4, h6, h10, h11.Corrected fields: d1 (brand name), g4 (510k number), 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
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol ventrio mesh on (b)(6) 2016.As reported, the patient is making a claim for an adverse patient outcome against the ventrio mesh.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) 2016 - patient was diagnosed with recurrent incarcerated ventral hernia thereby underwent open repair with implant of ventrio st mesh.Per op notes, ¿a multiloculated hernia sac was identified with peritoneal fat.The fat was reduced, and sac was freed.The major portion of prior synthetic mesh was excised.A ventrio st mesh was placed and sutured.A large amount of ascites in the abdominal cavity was removed.¿ (b)(6)2021 - patient was diagnosed with recurrent incarcerated incisional hernia, small bowel obstruction, acute respiratory failure, acute kidney injury, infected mesh, strangulation and sepsis thereby underwent open repair with excision of ventrio st mesh.Per op notes, ¿the incarcerated hernia sac was identified to the left of prior mesh and dissected.The mesh appeared to be infected.The hernia sac was opened contains large seroma which was drained.Necrotic small bowel was resected.The hernia sac and infected mesh was excised and primary closure with sutures.¿ (b)(6) 2021 ¿ patient passed away due to cardiopulmonary arrest, septic shock, incarcerated hernia with strangulation and small bowel obstruction.

• 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: 14514862
• Report Number: 1213643-2022-94130
• Device Sequence Number: 20440210
• Product Code: FTL
• UDI-Device Identifier: 00801741031533
• UDI-Public: (01)00801741031533(17)180528(10)HUAS1116
• 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: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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: 05/28/2018
• Device Catalogue Number: 5950040
• Device Lot Number: HUAS1116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2016
• 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; Death; Disability
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 141 KG