MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRIO MESH; SURGICAL MESH

Catalog Number 0010215

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 03/28/2019

Event Type  Injury  

Manufacturer Narrative

As reported the surgeon, inadvertently placed the polypropylene side of the mesh against the viscera.Root cause is determined to use related with no malfunction of the device.The surgeon and or staff were provided with training regarding the use (proper placement) of the ventrio mesh device.The placement of the polypropylene side of the mesh against the viscera is contraindicated per the instructions-for use."literature reports that there may be a possibility for adhesion formation when the polypropylene is placed in contact with the bowel or viscera." additionally the instructions-for-use state , "it is extremely important that this product is oriented correctly to function as intended.The smooth, solid white (eptfe) surface is designed with low porosity to minimize tissue attachment.Place this side of the prosthesis against those surfaces where minimal tissue attachment is desired, i.E., against bowel or other visceral structures.It is still recommended to pull down omentum wherever possible beneath the eptfe side to further mitigate the risk of visceral adhesion.The porous mesh side offers the same tissue in-growth characteristics of polypropylene mesh alone.Therefore, this surface should face the surface where tissue in-growth is desired.The mesh surface should never be placed against the bowel or other visceral structures.A review of the manufacturing records was performed and found that the lot was manufactured to specification with no anomalies noted discarded.

Event Description

The following was reported to bd/davol: (b)(6) 2019 - the patient underwent laparoscopic ventral hernia repair and was implanted with a bd/davol ventrio mesh.As reported there was some confusion regarding placement of the mesh orientation, by the or staff.After the case it was determined the mesh was placed incorrectly with the fascial side of the mesh placed against the viscera and the visceral side against the abdominal wall.The or nurse contacted bd/davol to confirm the orientation instructions.It was confirmed the mesh was placed incorrectly.(b)(6) 2019 - the patient underwent a revision procedure to remove the ventrio mesh and replace it with the ventralight st mesh w/ echo ps.As reported, the removal and replacement of the ventrio mesh with the ventralight st went well with no complications.

• Brand Name: VENTRIO MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 8515352
• MDR Text Key: 141966715
• Report Number: 1213643-2019-02967
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016424
• UDI-Public: (01)00801741016424
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2021
• Device Catalogue Number: 0010215
• Device Lot Number: HUBY1359
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2018
• 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