MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO 2 SURGICAL MESH

Catalog Number 5990015

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned for evaluation. The sample evaluation confirms for torn frame material resulting in the detachment of a portion of the frame. No manufacturing anomalies were found. As reported, the issue presented when the user attempted to remove the echo 2 ps through an 8mm trocar. The instructions-for-use (ifu) recommends the use of a 12mm trocar size for the product code used. Evaluation of the sample found that the echo ps 2 frame material was inadvertently torn most likely due to forces applied while removing the frame through a 8mm trocar. Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported. To date, this is the only complaint reported for this manufacturing lot of (b)(4) units released for distribution in march, 2021.

Event Description

As reported, during a laparoscopic ventral hernia repair with a 2 cm defect on (b)(6) 2021, the surgeon used a bard/davol ventralight st mesh w/echo 2 positioning system. As reported, a 10mm camera port and x2 8mm ports were used for the mesh insertion/removal. Following placement and fixation of the ventralight st mesh, the surgeon attempted to remove the echo 2 ps frame through the 8 mm port, and one of the "spokes" detached from the frame. The detached portion (spoke) of the frame was completely removed along with the rest of the frame and there was no delay in the case. The surgeon is an experienced user of the device. There was no reported patient injury.

• Brand Name: VENTRALIGHT ST W/ ECHO 2
• 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: 12287314
• MDR Text Key: 265368499
• Report Number: 1213643-2021-20236
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/28/2021
• Device Catalogue Number: 5990015
• Device Lot Number: HUFN0601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/06/2021 Patient Sequence Number: 1