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

Catalog Number 5954450

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2020

Event Type  malfunction  

Manufacturer Narrative

At this time, no conclusion can be made.While the sample evaluation is anticipated it has not get begun.To date this is the only reported complaint for this manufacturing lot.Review of the manufacturing records is in process.When the investigation has been completed, a supplemental emdr will be submitted.

Event Description

As reported, while performing a laparoscopic incisional hernia repair procedure, it was discovered that the adhesive coating was peeling off the ventralight st mesh.There was a minimal delay and the procedure was completed using another device.There was no reported patient injury.

Event Description

As reported, while performing a laparoscopic incisional hernia repair procedure, it was discovered that the adhesive coating was peeling off the ventralight st mesh.There was a minimal delay and the procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

At this time, no conclusion can be made.While the sample evaluation is anticipated it has not get begun.To date this is the only reported complaint for this manufacturing lot.Review of the manufacturing records is in process.When the investigation has been completed, a supplemental emdr will be submitted.Addendum: this is an addendum to the initial emdr submitted on 20-may-2020 to document the results of device evaluation.It was reported that the st coating was separating from areas of the ventralight st mesh; evaluation of the sample confirmed the event as reported.The separation had resulted in a void of the hydrogel barrier.The mesh had been previously hydrated but it is unknown for how long hydration took place.Sutures were placed in the mesh during preparation for use, however, it is unknown if the sutures were placed prior to hydration.Per the laparoscopic use section in the instructions-for-use, "the "ventralight¿ st mesh should be hydrated for no more than 1-3 seconds just prior to laparoscopic placement.If sutures are being placed, attach the sutures to the ventralight¿ st mesh before hydration.The prosthesis must be rolled immediately after hydration about its long axis (lengthwise) with the bioresorbable coating inside to protect the bioresorbable coating." there was no damage reported to the hydrogel prior to attempted use of the device and no manufacturing anomalies were found.It is possible that the damage inadvertently occurred during subsequent handling and preparation for use.However, based on the available information and product evaluation a definitive conclusion cannot be made.A review of manufacturing records indicate product was manufactured to specification.Updated fields: b4, g4, g7, h2, h3, h6, h10.

• Brand Name: VENTRALIGHT ST MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10075479
• MDR Text Key: 193038765
• Report Number: 1213643-2020-04942
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031618
• UDI-Public: (01)00801741031618
• Combination Product (y/n): N
• PMA/PMN Number: K101851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2020
• Device Catalogue Number: 5954450
• Device Lot Number: HUCP2569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Date Manufacturer Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1