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

Catalog Number	0010212
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abscess (1690); Impaired Healing (2378); Drug Resistant Bacterial Infection (4553)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, about 2 years, post implant of a bard/davol ventrio hernia patch , the patient was diagnosed with a surgical site infection (mrsa), and suture abscess and subsequently underwent explant of the mesh.As reported, the ae is resolved.The clinician has assessed the patient¿s postoperative course as being "possibly" related to the study device and to the index procedure, however, based on the information provided, no conclusions can be made.Infection is an known inherent risk of surgery.The instruction-for-use (ifu) supplied with the device lists infection as a possible complication.Regarding infection, the warnings 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." review of the manufacturing records shows the device was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 185 units released for distribution in october, 2015.Not returned - remains implanted.
Event or Problem Description
Reported per clinical trial (b)(6): on (b)(6) 2016 - subject patient underwent primary open ventral periumbilical hernia repair procedure, during which a bard/davol ventrio hernia patch was placed in underlay fashion intra-peritoneally using anterior cst method, using non-bard/davol mechanical fixation device and sutures.Fascia and full skin closure was achieved using sutures and staples.The patient was discharged on (b)(6) 2016.On (b)(6) 2018 - subject patient was diagnosed with surgical site infection, was treated with oral antibiotics, and underwent wound debridement.The ssi was deep layer and the culture tested positive for methicillin-resistant staphylococcus aureus (mrsa).The subject patient was also diagnosed with chronic wound draining at the sinus tract, which is likely secondary to suture abscess.On (b)(6) 2018 - subject patient underwent ventral periumbilical repair for ssi and chronic wound draining.Fascia and full skin closure was achieved using sutures.The patient was discharged on (b)(6) 2018.On (b)(6) 2018 - subject patient was diagnosed with mesh infection.On (b)(6) 2018 - subject patient underwent laparotomy ventral periumbilical repair for mesh infection, during this procedure the mesh was explanted.Fascia and full skin closure was achieved using sutures.The patient was discharged on (b)(6) 2018.Per the study clinician, the reported adverse events have been assessed as moderate to severe, possibly related to the study device and possibly related to the index procedure.The outcome reported as recovered/resolved.

• Brand Name: VENTRIO MESH
• 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 ; 8005566756
• MDR Report Key: 14517690
• Report Number: 1213643-2022-00353
• Device Sequence Number: 5502359
• Product Code: FTL
• UDI-Device Identifier: 00801741016394
• UDI-Public: (01)00801741016394
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2022

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: 03/28/2019
• Device Catalogue Number: 0010212
• Device Lot Number: HUZH1268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2015
• 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
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 106 KG