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

Catalog Number 5955450

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hernia (2240)

Event Date 09/13/2018

Event Type  Injury  

Event Description

Reported per clinical trial (b)(4): (b)(6) 2016 - subject patient underwent a robotic assisted multiple recurrent midline hernia (8cm x 30cm) repair procedure during which two bard/davol ventralight st using echo ps were implanted using sutures.Full skin closure was achieved using sutures and adhesive skin closure.The patient was discharged from the hospital on(b)(6) 2017.(b)(6) 2018 - subject patient was diagnosed with recurrent ventral midline infraumbilical incisional hernia.(b)(6) 2018 - subject patient underwent surgery to repair the hernia (4.5cm x 10cm) recurrence and was implanted with bard/davol ventralight st using echo ps.The fascia was completely closed using sutures and full skin closure was achieved.The patient was discharged from the hospital on (b)(6) 2018.Per the study clinician, the reported adverse event has been assessed as severe, possibly related to the study device and possibly related to the index procedure.The outcome for this ae is reported as recovered/resolved.

Manufacturer Narrative

As reported, about two years post-implant of ventralight st using echo ps, the patient was diagnosed with a recurrent ventral incisional hernia for which the patient underwent surgical intervention.As reported, the ae has resolved.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and possibly related to the index procedure, however, based on the information provided, no conclusion can be made.Hernia recurrence is a known inherent risk of hernia repair surgery.The instructions-for-use (ifu) supplied with the device lists hernia recurrence as a possible complication.This mdr represents one of the ventralight st w/echo devices used during the (b)(6) 2016 surgery.An additional mdr was submitted to represent the other ventralight st w/echo used during the (b)(6) 2016 surgery.Not returned - remains implanted.

• 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: 14488800
• MDR Text Key: 292969399
• Report Number: 1213643-2022-00308
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031717
• UDI-Public: (01)00801741031717
• 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: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• 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: 5955450
• Device Lot Number: HUAV0445
• 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
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 97 KG