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

Catalog Number	5955800
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, several months post implant of a ventralight st mesh using echo ps the patient was diagnosed with a hernia recurrence and underwent mesh removal several years later.An intraoperative photo showing the hernia recurrence was provided.The explanted mesh was returned for evaluation.Review of the mesh finds for a hole in the mesh and there are two sutures present within the mesh.One small piece of suture is bright blue at the outer edge of the mesh.The other suture is almost black in color and thicker than the other suture which is tied in the area of the hole in the mesh.It was alleged the hole in the mesh was in the area where the inflation tube is placed, on center.Evaluation shows the hole in the mesh is not in the center of the implant.The patient experienced a hernia recurrence, and it was reported the bowel pushed through in the hole in the mesh.The surgeon had not performed primary closure of the defect in a tension free repair.It appears the area of the mesh where the hole and suture are located experienced forces sufficient to separate the material.The hernia recurrence that presented does not appear to have been related to the use of the device after expiration.Review of manufacturing records shows product was manufactured to specification.This mdr represents the post operative hernia recurrence.An additional mdr was submitted to represent the expired mesh implantation.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.
Event or Problem Description
As reported, during repair of a hernia defect on (b)(6) 2019, the patient was implanted with ventralight st mesh using echo ps, the surgeon did not close the defect and used tacks to make a double crown.As reported a few months later, the patient was diagnosed with a hernia recurrence directly in the middle of the mesh where the bowels were pushing through a new defect hole.On (b)(6) 2024, the patient underwent a reoperation by removing the completely peritonalized mesh.The hernia defect was closed with sutures and another ventralight st mesh was used to complete the repair.Reportedly the hole was in the middle of the mesh were the tubing of the echo ps goes through.It was noted upon review of the information provided that the mesh has a labeled expiration date on 28-oct-2018 and was implanted in (b)(6) 2019.This mdr represents post operative hernia recurrence.

• Brand Name: VENTRALIGHT ST W/ ECHO
• Common Device Name: SURGICAL 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 Key: 19460041
• Report Number: 1213643-2024-00285
• Device Sequence Number: 7926285
• Product Code: FTL
• UDI-Device Identifier: 00801741031779
• UDI-Public: (01)00801741031779
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2018
• Device Catalogue Number: 5955800
• Device Lot Number: HUAX1033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female