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

Catalog Number	5950050
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446)
Date of Event	06/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, post-implant of the ventrio st mesh, the patient experienced bowel obstruction and adhesions and underwent surgical intervention.Also reported was that the patient developed a superficial surgical site infection following the second procedure.Intraoperative photos provided from the second procedure did not assist in determining a root cause of the reported postoperative complications.Based on the information available, no conclusions can be made.To date, this is the only reported complaint from this manufacturing lot.Adhesion and infection are known inherent risks of surgery.The instructions-for-use (ifu) supplied with the device lists adhesions, and infection 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." note, the date of event is considered to be a best estimate as (b)(6) 2021.Should additional information be provided, a supplemental mdr will be submitted.
Event or Problem Description
As reported, the patient underwent an abdominal wall reconstruction and ventral hernia repair using a bard/davol ventrio st.Post implant, about two weeks later, the patient presented with bowel obstruction which required surgery.During the surgery, it was found that the omentum and several loops of small bowel were densely adhered to the mesh.The small bowel mesentery had volvulized around the adherent loops which was intervened quickly without any requirement for bowel resection.As reported, the patient remained hospitalized with an ileus and has developed a superficial surgical site infection.

• 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
• MDR Report Key: 12195208
• Report Number: 1213643-2021-20187
• Device Sequence Number: 17021541
• Product Code: FTL
• UDI-Device Identifier: 00801741031540
• UDI-Public: (01)00801741031540
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2021

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: 07/28/2022
• Device Catalogue Number: 5950050
• Device Lot Number: HUEU0550
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention