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

Catalog Number UNKAA078

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bacterial Infection (1735); Necrosis (1971); Seroma (2069); Hernia (2240)

Event Date 03/01/2014

Event Type  Injury  

Manufacturer Narrative

Based on the information available, no conclusions can be made.The information obtained is limited to the journal article.Postoperative seroma, hernia recurrence and infection are known inherent risks of surgery/use of the device and are included as possible complications in the adverse reactions section of the instructions-for-use (ifu), supplied with the device.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." no lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event (01-mar-2014) is provided as an estimate based on the information provided.This mdr represents the ventralight st mesh.An additional mdr was submitted to represent the soft mesh.Not returned.

Event Description

Per journal article: "preventing recurrence in clean and contaminated hernias using biologic versus synthetic mesh in ventral hernia repair" (ann surg 2021; 273:648¿655).The aim of this study: to evaluate which mesh type (synthetic vs.Biological mesh) yields lower recurrence and complication rates after ventral hernia repair.Conclusion: the risk of hernia recurrence was significantly higher for patients undergoing ventral hernia repair with biologic mesh compared to synthetic mesh, with similar rates of postoperative complications.These data indicate that the use of synthetic mesh over biologic mesh to repair ventral hernias is effective and can be endorsed, including under contaminated wound conditions.Clinical trial conducted from march 2014 through october 2018.165 patients enrolled with an average follow up of 26 months.Patients were randomized (1:1 ratio).All hernia repair procedures were performed using either a biologic (porcine strattice mesh) or synthetic (polypropylene ventralight st or soft mesh) mesh.As reported, between march 2014 to oct 2018, a total of 165 patients in which 83 patients underwent ventral hernia repair using synthetic mesh and 82 patients underwent hernia repair using biologic mesh.14 patients (21.9%) assigned to synthetic mesh reported hernia recurrence.Secondary outcomes were postoperative complications included, mesh infection, seroma, wound necrosis and (5) mesh explants.Article does not provide case/product specific information to know which patient were implanted with what device and experienced what complications.

• Brand Name: VENTRALIGHT ST 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: 16239973
• MDR Text Key: 308078902
• Report Number: 1213643-2023-00011
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2023

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 Catalogue Number: UNKAA078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention