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

Catalog Number 5950009

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Wound Dehiscence (1154); Cellulitis (1768); Unspecified Infection (1930)

Event Date 02/26/2018

Event Type  Injury  

Event Description

Reported per clinical trial (b)(6): on (b)(6) 2016: subject patient underwent an open technique procedure for primary right upper quadrant incisional hernia repair using a small bard/davol ventralex st mesh, primary left upper quadrant incisional hernia repair using a medium ventralex st mesh and incisional hernia repair using a large ventralex st mesh, which were fixated using sutures full skin closure was achieved using staples and sutures.The patient was discharged from the hospital on (b)(6) 2016.On (b)(6) 2018: patient presented to emergency department with fever, chills, weakness and redness of abdomen.Patient admitted and diagnosed with cellulitis secondary to infected mesh.Ct imaging showed infection of the mesh.Wound dehiscence was noted, the mesh (large ventralex st mesh) was intact.Patient was diagnosed with a superficial incisional surgical site infection (ssi) and treated with intravenous antibiotics.The patient was discharged from hospital on (b)(6) 2018.As reported, the subject was implanted with a non-study mesh in addition to study mesh at the index procedure and it cannot be determined which mesh caused the infection.Per the study clinician, the reported adverse event (mesh infection, wound dehiscence) has been assessed as moderate in severity, possibly related to the large ventralex st mesh and indeterminate to the index procedure.The outcome for this ae is reported as recovered/resolved.The reported adverse event (cellulitis) has been assessed as moderate in severity, possibly related to the large ventralex st mesh and definitely related to the index procedure.The outcome for this ae is reported as recovering/resolving.

Manufacturer Narrative

As reported, about 1.3 years post-implant of the large ventralex st mesh, the patient was diagnosed with mesh infection (ssi), wound dehiscence and cellulitis of the trunk and was treated with intravenous antibiotics.As reported, the ae of mesh infection is recovered/resolved and the ae of cellulitis is resolving.The clinician has assessed the patient¿s postoperative course of mesh infection and cellulitis as being moderate, and possibly related to the study device, however, based on the information provided no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of 189 units released for distribution in september, 2016.Infection is a known inherent risk of surgery.The adverse reactions section of the instructions-for-use, supplied with the device lists infection as a possible complication.In regards to the 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 prosthesis.An unresolved infection may require removal of the prosthesis." this mdr represents the large ventralex st mesh.Two additional mdrs were submitted to represent the small ventralex st mesh and medium ventralex st mesh.Not returned - remains implanted.

• Brand Name: VENTRALEX ST
• 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: 14495194
• MDR Text Key: 292586530
• Report Number: 1213643-2022-00329
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031496
• UDI-Public: (01)00801741031496
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101928
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2018
• Device Catalogue Number: 5950009
• Device Lot Number: HUAU1600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2016
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 115 KG