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

Catalog Number 0010212

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bacterial Infection (1735); Erythema (1840); Seroma (2069); Post Operative Wound Infection (2446)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

As reported, about 3 months post implant of the bard/davol ventrio mesh, the patient diagnosed with a series of post-surgical complications including infected abdominal wall seroma, erythema, chronic wound and was treated with medications and underwent partial explant of the mesh.As reported, the aes (seroma, erythema and surgical site infection) are resolved and the ae (chronic wound) is resolving.The clinician has assessed the patient¿s postoperative course of seroma, erythema and surgical site infection as being "possibly" related to the study device and definitely related to the procedure and the ae of chronic wound as being "definitely" related to the study device and to the procedure, however, based on the information provided, no conclusion can be made.Infection and seroma are known inherent risk of surgery.The instructions-for-use supplied with the device lists infection and seroma as possible complications.In regards to the infection, the warning section of the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." a review of the manufacturing records was performed and found that the lot was manufactured to specification.This mdr represents the ventrio mesh (device 2).An additional mdr was submitted to represent the ventrio st mesh (device 1).Not returned - partially explanted.

Event Description

Alleged per clinical trial (b)(4): (b)(6) 2018, the patient underwent primary open ventral incisional hernia repair, during which a bard/davol ventrio st (device 1) was placed in underlay fashion intra-peritoneally using anterior cst method, fixated using non-bard/davol maxon sutures with 8 fixation points.Fascia and full skin closure was achieved using non-bard/davol maxon interrupted stitches and staples.The patient was discharged to home on (b)(6) 2018.(b)(6) 2019 ¿ patient diagnosed with a ¿recurrent, reducible, incisional ventral hernia¿ (there is no determination this event is related to the previously implanted mesh (device 1)) (b)(6) 2020, the patient underwent primary open ventral incisional hernia repair, during which a bard/davol ventrio (device 2) was placed in underlay fashion, fixated using non-bard/davol silk sutures.Fascia and full skin closure was achieved using non-bard/davol silk interrupted stitches and running stitches.The patient was discharged to home on (b)(6) 2020.(b)(6) 2020, patient experienced abdominal wall seroma with overlying erythema.(b)(6) 2020, the patient was diagnosed with surgical site infection.The patient underwent an reoperation and the culture tested positive for bacteria (staphylococcus aureus).The patient was treated with intravenous and topical antibiotics and drain was placed.The patient was discharged to home on (b)(6) 2020.(b)(6) 2020, the patient was diagnosed with chronic wound draining at the sinus tract.The patient experienced chronic wound draining sinus tract.(b)(6) 2020, the patient had undergone reoperation for seroma.Fascia closure was achieved using a non bard/davol vicryl sutures.The skin closure was not achieved.Partial removal of both implanted mesh was performed during this procedure.The ae is clinically assessed to be definitely related to the study device and definitely related to the procedure.

• Brand Name: VENTRIO MESH
• Type of Device: 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: 14498765
• MDR Text Key: 293164521
• Report Number: 1213643-2022-00343
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016394
• UDI-Public: (01)00801741016394
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2021
• Device Catalogue Number: 0010212
• Device Lot Number: HUCP2089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 89 KG