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

Catalog Number UNKAA077

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Sepsis (2067); Hernia (2240); Post Operative Wound Infection (2446)

Event Date 01/01/2007

Event Type  Injury  

Event Description

Per journal article: reoperation for recurrence is affected by type of mesh in laparoscopic ventral hernia repair: a nationwide cohort study.Annals of surgery purpose: to compare the reoperation rate for recurrence between different mesh types in laparoscopic ventral hernia repair in patients with primary and incisional hernias.Conclusion: for primary hernias, physiomesh and proceed surgical mesh had a significantly higher risk of reoperation for recurrence compared with dynamesh-ipom.For incisional hernias, the risk was significantly higher for physiomesh, parietex composite, ventralex hernia patch, and proceed surgical mesh compared with ventralight st mesh.This indicates that type of mesh may be associated with outcomes, and mesh choice could therefore depend on hernia type.Patients had undergone laparoscopic ventral hernia repair with an intraperitoneally placed mesh between 01-jan-2007 and 01-apr-2020.The mesh could be fixated with either absorbable or permanent tacks.In this study, the patients were divided into two separate cohorts and each cohort, patients were grouped depending on the mesh they had received.Three bard/davol implants were included in the review.Ventralight st (387 patients) 11 abdominal pain, 1 sepsis, 1 superficial wound infection, and 14 reoperations for hernia recurrence.Ventralex (341 patients) 2 abdominal pain, 2 superficial wound infection, 1 sepsis and 20 reoperations for hernia recurrence.Composix l/p (56 patients)1 hematoma, 9 reoperations for hernia recurrence.Article does not provide case/product specific information.

Manufacturer Narrative

Based on the information available, no conclusions can be made.Hernia recurrence, infection and pain 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.In regards to 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 patch.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 (b)(6) 2007) is provided as an estimate based on the information provided.This mdr represents the mesh ¿ ventralex.An additional mdrs were submitted to represent the ventralight st mesh and mesh ¿ composix l/p.

• Brand Name: MESH ¿ VENTRALEX
• 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: 16241081
• MDR Text Key: 308096852
• Report Number: 1213643-2023-00017
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K132441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• 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