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

Catalog Number 5955680

Device Problem Torn Material (3024)

Patient Problem Hernia (2240)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

At this time no definitive conclusions can be made.A review of the manufacturing records has been performed.No manufacturing issues associated to the reported event were found in the reviewed lot.All process steps were completed per manufacturing procedures, inspection procedures, as documented in the work order.Product passed all required inspections.There were no manufacturing abnormalities.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in (b)(6) 2016.Review of the bard device in question is not possible as the mesh remains implanted.However, intraoperative photos were provided and have been reviewed.Based on review of the photos this complaint is confirmed for having a tear in the center of the mesh as was reported.Information regarding the implant procedure is limited.Although it is not evident in the images provided, it is possible that the mesh may have been damaged during insertion/implant.Regarding recurrence, the warning section of the instructions-for-use, which is supplied with the device, states, "to prevent recurrences when repairing hernias.It is recommended that the prosthesis be large enough to extend at least 3 to 5 cm beyond the margins of the defect." it was noted that a larger mesh (26x36 cm) was placed during the revision procedure to repair the hernia.The mesh used during the initial repair was 15.2 x 20.3 cm in size.Should additional information be provided, a supplemental emdr will be submitted.The information provided by bard 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 bard.Remains implanted.

Event Description

It was reported that on (b)(6) 2018 the patient underwent laparoscopic ventral hernia repair with a bard ventralight st w/ echo ps device.As reported the gap +/- 6cm was closed with a v-loc 180 and the ventralight st implant was placed against the abdominal wall and fixated with bard optifix fixation device.After completion of the procedure, during awakening, while putting the belly band on, the patient coughed.At that moment the nurse heard a popping sound and saw a bulge.They went back laparoscopically to see what happened and they saw that the mesh was ruptured and was fully torn in the middle.A revision procedure was performed in an open method.The ventralight st implant was left in place and a davol flat mesh (26x36 cm) was placed over the previously placed implant.The doctor provided no opinion as to why the problem presented.

• Brand Name: VENTRALIGHT ST W/ ECHO
• 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: 7299033
• MDR Text Key: 101024962
• Report Number: 1213643-2018-00390
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031755
• UDI-Public: (01)00801741031755
• Combination Product (y/n): N
• PMA/PMN Number: K122436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2018
• Device Catalogue Number: 5955680
• Device Lot Number: HUAP0717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2016
• 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
• Patient Age: 84 YR
• Patient Weight: 80