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

Catalog Number 5955113

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Hernia (2240)

Event Date 07/08/2017

Event Type  Injury  

Manufacturer Narrative

As reported, about 3 years post implant of the bard/davol ventralight st mesh using echo ps, the patient was diagnosed with hernia recurrence.As reported, the ae has not resolved and the patient has been advised to lose weight before a surgery could be performed.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and to the procedure, however, based on the information provided, no conclusion can be made.Hernia recurrence is a known inherent risk of hernia repair surgery.The adverse reactions section of the instructions-for-use, supplied with the device lists hernia recurrence as a possible complication.Review of manufacturing records confirms product was manufactured to specification.This mdr represents the adverse event of hernia recurrence.An additional mdr was submitted to represent the adverse event of seroma.Device not returned - remains implanted.

Event Description

Reported per clinical trial dvl-he-020: on 03-jun-2014- subject patient underwent robotic assisted incisional hernia repair procedure.A bard/davol ventralight st was implanted using echo ps and fixated with bard/davol sorbafix fixation device and sutures.The size of the hernia defect was 30cm.Full skin closure was achieved using adhesive skin closure.On 08-jul-2017- subject patient presented to emergency department with abdominal pain and the patient's ct scan revealed ventral incisional recurrent hernia.As reported, the surgeon advised the patient that a surgery could not be performed until the bmi reduces to <50.As reported, the patient had not returned yet.Per the study clinician, the reported adverse event has been assessed as severe in severity, possibly related to the study device and possibly related to the index procedure.The outcome for this ae is reported has not recovered/not resolved.

• Brand Name: VENTRALIGHT ST W/ ECHO
• 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: 14468981
• MDR Text Key: 292360205
• Report Number: 1213643-2022-00280
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031694
• UDI-Public: (01)00801741031694
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122436
• 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: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2015
• Device Catalogue Number: 5955113
• Device Lot Number: HUXJ1813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2013
• 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
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 161 KG