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

Catalog Number 5955600

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hernia (2240)

Event Date 05/24/2017

Event Type  Injury  

Manufacturer Narrative

As reported, about 6 months post-implant of the ventralight st mesh using echo ps, the patient was diagnosed with hernia recurrence through imaging.As reported, the ae is resolving.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and possibly related to the procedure, however, based on the information provided, no conclusion can be made.Hernia recurrence is a known inherent risk of surgery.The adverse reactions section of the instructions-for-use supplied with the device lists hernia recurrence as a possible complication.This mdr represents the ae of hernia recurrence.An additional mdr was submitted to represent the ae of seroma.Not returned - remains implanted.

Event Description

Reported per clinical trial (b)(4): (b)(6) 2016 - subject patient underwent first time recurrent robotic-assisted procedure for incarcerated, ventral, incisional hernia repair at the llq.The size of the hernia defect was 3cm x 3cm.A bard/davol ventralight st was placed using echo ps and was fixated with sutures.Fascia and full skin closure was achieved using sutures.The patient was discharged to home on (b)(6) 2016.(b)(6) 2016 - subject patient presented with a "large bulge" (seroma) during the 1st post-op visit.Per the study clinician, the reported adverse event has been assessed as moderate in severity, possibly related to the study device and definitely related to the index procedure.The reported ae has resolved.(b)(6) 2017 - follow up appointment, ultrasound-guided aspiration was ordered.Per ultrasound large hernia without fluid.No aspiration attempted.The patient was diagnosed with recurrent abdominal wall hernia.Per the study clinician, the reported adverse event has been assessed as moderate, possibly related to the study device and possibly related to the index procedure.The outcome for this ae is reported as recovering/resolving.

• 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: 14490215
• MDR Text Key: 293455939
• Report Number: 1213643-2022-00318
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031731
• UDI-Public: (01)00801741031731
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130968
• 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: 09/28/2018
• Device Catalogue Number: 5955600
• Device Lot Number: HUAW0658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/24/2022
• 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
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 113 KG