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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO; SURGICAL MESH
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DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO; SURGICAL MESH Back to Search Results
Catalog Number 5955600
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/16/2021
Event Type  malfunction  
Manufacturer Narrative
As reported, the bard/davol ventralight st w/echo ps mesh was stuck in the trocar and the hydrogel barrier separated.It is reported that the subject device is being returned for evaluation; however at this time it has not been received.Based on the information available, no conclusions can be made.A review of manufacturing records indicate product was manufactured to specification.To date, this is the only complaint reported for this manufacturing lot of 112 units released for distribution in (b)(4) 2020.If/when the sample is returned and evaluated, a supplemental mdr will be submitted.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
As reported, during a laparoscopic ipom procedure on (b)(6) 2021, the bard/davol ventralight st mesh w/ echo ps was hydrated for 1-3 seconds, rolled and inserted through a 10mm trocar.The mesh got stuck in the trocar and could not be rolled out.The surgeon tried pulling the mesh through with the grasping forceps, this did not help.The mesh was withdrawn from the trocar, rolled out and rolled back up to be reinserted.It was noticed that the st barrier was no longer present at one point.As reported, the mesh may not have been rolled tight enough, therefore got stuck in the trocar and was damaged during removal from the trocar with the grasping forceps.The ventralight st mesh was discarded and a bard/davol ventralight st mesh w/ echo 2 ps was used to complete the case.There was no reported patient injury.The surgeon is a new user of this product.
 
Event Description
As reported, during a laparoscopic ipom procedure on (b)(6) 2021, the bard/davol ventralight st mesh w/ echo ps was hydrated for 1-3 seconds, rolled and inserted through a 10mm trocar.The mesh got stuck in the trocar and could not be rolled out.The surgeon tried pulling the mesh through with the grasping forceps, this did not help.The mesh was withdrawn from the trocar, rolled out and rolled back up to be reinserted.It was noticed that the st barrier was no longer present at one point.As reported, the mesh may not have been rolled tight enough, therefore got stuck in the trocar and was damaged during removal from the trocar with the grasping forceps.The ventralight st mesh was discarded and a bard/davol ventralight st mesh w/ echo 2 ps was used to complete the case.There was no reported patient injury.The surgeon is a new user of this product.
 
Manufacturer Narrative
As reported, the bard/davol ventralight st w/echo ps mesh was stuck in the trocar and the hydrogel barrier separated.It is reported that the subject device is being returned for evaluation; however at this time it has not been received.Based on the information available, no conclusions can be made.A review of manufacturing records indicate product was manufactured to specification.To date, this is the only complaint reported for this manufacturing lot of (b)(4) units released for distribution in february 2020.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the results of the device evaluation.It was reported that the ventralight st mesh was stuck and the st coating was separating from areas of the mesh during attempted deployment via a 10mm trocar.The subject product was returned for evaluation.Visual evaluation confirms sections of the st (sepra) coating have separated from the mesh.Voids are noted in the material, however hydrogel is still present in the large areas where the hydrogel material stuck together.No manufacturing anomalies were found.The instructions-for-use (ifu) recommends the use of a 12mm trocar size for the product code used.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 10mm trocar.Per the laparoscopic use section in the ifu, "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." note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text: sample evaluated.
 
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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
MDR Report Key11852105
MDR Text Key251680712
Report Number1213643-2021-20123
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741031731
UDI-Public(01)00801741031731
Combination Product (y/n)N
PMA/PMN Number
K130968
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/28/2021
Device Catalogue Number5955600
Device Lot NumberHUDZ0835
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2021
Date Manufacturer Received05/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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