• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST MESH SURGICAL MESH Back to Search Results
Catalog Number 5954600
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/10/2021
Event Type  malfunction  
Manufacturer Narrative
As reported, the sepra (st) coating of the ventralight st mesh separated during attempted deployment via an 8mm trocar (note, per the ifu a 10mm trocar is recommended for cat# 5954600). The subject product was returned for evaluation. Evaluation of the sample finds the st coating to have separated from areas on the mesh, resulting in a void of the hydrogel barrier. The separation of the hydrogel coating is the result of the attempted deployment through the 8mm trocar. The trocar used in the case was also returned with the mesh sample and is confirmed to be an 8mm trocar. Based on the sample evaluation and investigation performed, the root cause is determined to be inadvertent damage to the st hydrogel barrier during user/device interface while handling the hydrated mesh and deploying down the 8mm trocar. To date, this is the only reported complaint for this manufacturing lot. Per the laparoscopic use section in the instructions-for-use, ¿a minimum sized trocar is recommended for the laparoscopic delivery of ventralight st mesh (recommended to use a 10mm trocar for cat# 5954600). Insert the prosthesis through the trocar using a rigid instrument, such as non-serrated, 5 mm forceps; do not over force the prosthesis through trocar. If ventralight st mesh is hydrated longer than 3 seconds and/or does not easily deploy down the trocar, replace trocar and retry with the next available larger sized trocar. ".
 
Event Description
As reported, during a laparoscopic ventral hernia repair procedure on (b)(6) 2021, the bard/davol ventralight st mesh was hydrated approximately 1-3 seconds, rolled with the st coating inside and inserted through an 8 mm trocar. As reported, when the surgeon unrolled the mesh, the st coating was noted to be separating. As reported, the mesh was removed and a non-bard/davol mesh was used to complete the procedure. There was no reported patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVENTRALIGHT ST MESH
Type of DeviceSURGICAL 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 Key12396526
MDR Text Key269402760
Report Number1213643-2021-20290
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5954600
Device Lot NumberHUFN0308
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2021
Was Device Evaluated by Manufacturer? Yes
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: 08/31/2021 Patient Sequence Number: 1
-
-