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); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Insufficient Information (4580)
Date of Event	01/03/2019
Type of Reportable Event	Serious Injury
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 #1).Additional emdrs were submitted to represent the bard/davol ventrio st (device #2) and three bard/davol ventralight st mesh(device #3, device #4 and device #5).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 st (x2) on (b)(6) 2016 (x2) and 3dmax and ventralight st (x3) on (b)(6) 2018 and/or (b)(6) 2019 and/or (b)(6) 2019 and/or (b)(6) 2020.As reported, the patient is making a claim for an adverse patient outcome against the ventrio st (x2) and ventralight st (x3).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 #1).Additional emdrs were submitted to represent the bard/davol ventrio st (device #2) and three bard/davol ventralight st mesh(device #3, device #4 and device #5).Should additional information be provided, a supplemental emdr will be submitted.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-aug-2016) is considered to be a best estimate.This supplemental emdr represents the bard/davol mesh ¿ ventrio st (device #1).Additional supplemental emdr's were submitted to represent the bard/davol - ventrio st mesh (device #3), bard/davol - ventralight st mesh (device #4), bard/davol - ventralight st mesh (device #5), bard/davol - ventralight st using echo ps mesh (device #6).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 unspecified bard/davol ventrio st (x2) on (b)(6) 2016 (x2) and 3dmax and ventralight st (x3) on (b)(6) 2018 and/or (b)(6) 2019 and/or (b)(6) 2019 and/or (b)(6) 2020.As reported, the patient is making a claim for an adverse patient outcome against the ventrio st (x2) and ventralight st (x3).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 incarcerated incisional hernia and large sliding left inguinal hernia thereby underwent laparoscopic repair with the implant of ventrio st mesh (device #1) for ventral hernia and 3dmax mesh (device #2) for left inguinal hernia.Per op notes, ¿the preperitoneal fat was taken down around the ventral hernia.A round ventrio st mesh (device #1) was placed intracorporeally and tacked circumferentially using the sorbafix tacker.On left groin, large 3dmax mesh (device #2) was placed into hernia defect and tacked along cooper's ligament using the sorbafix tacker.¿ (b)(6) 2018 ¿ patient was diagnosed with recurrent epigastric hernia thereby underwent laparoscopic repair with the implant of ventrio st mesh (device #3).Per op notes, ¿the patient is noted to have adhesions to the epigastric area which were adherent to the previously placed mesh (device #1) were taken down.A large ventrio st mesh (device #3) was placed into the abdominal cavity and tacked using sorbafix.¿ (b)(6) 2019 ¿ patient was diagnosed with recurrent epigastric hernia thereby underwent robotic assisted repair with the removal of ventrio st meshes (device #1, #3) and implant of ventralight st mesh (device #4).Per op notes, ¿the patient is noted to have adhesions of the omentum in the peri umbilical area were taken down.The lateral aspect of the mesh (device #1, #3) placed in the epigastric region was removed along with hernia sac.A circular ventralight st mesh (device #4) was placed into the abdomen and sutured.¿ (b)(6) 2019 ¿ patient was diagnosed with recurrent epigastric hernia thereby underwent robotic repair with the implant of ventralight st mesh (device #5).Per op notes, ¿the patient is noted to have adhesions of the omentum in the epigastric area were taken down.A recurrent epigastric hernia just cephalad to the previously placed mesh (device #4).A circle ventralight st mesh (device #5) was placed into the abdomen and sutured.¿ (b)(6) 2020 ¿ patient was diagnosed with recurrent ventral hernia thereby underwent robotic assisted repair with the removal of mesh (device #4, #5) and implant of ventralight st using echo ps mesh (device #6).Per op notes, ¿patient is noted to have adhesions of the omentum in were to the previously placed mesh (device #4, #5) in the epigastric and periumbilical area were taken down.The cephalad aspect of the previously placed mesh (device #4, #5) were also removed.A ventralight st using echo ps (device #6) was placed into the abdomen and sutured.¿ (b)(6) 2021 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the removal of mesh (device #6) and implant of marlex mesh (device #7).Per op notes, ¿there were more adhesions of omentum and small bowel around the periphery were taken down.The hernia sac and old mesh (device #6) were excised.A marlex mesh (device #7) was placed into posterior portion and secured circumferentially.¿.

• 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: 12562627
• Report Number: 1213643-2021-07968
• Device Sequence Number: 13806774
• Product Code: FTL
• UDI-Device Identifier: 00801741031502
• UDI-Public: (01)00801741031502(17)180828(10)HUAV0117
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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: 08/28/2018
• Device Catalogue Number: 5950010
• Device Lot Number: HUAV0117
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2016
• 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; Disability
• Patient Age: 53 YR
• Patient Sex: Male