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

Catalog Number	5954680
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	10/14/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, post implant of ventralight st mesh, patient had hernia recurrence and underwent mesh removal.Per op notes, "mesh was pulled out from one side and removed completely".The instructions-for-use supplied with the device lists hernia recurrence as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This emdr represents the ventralight st mesh (device #2).An additional supplemental mdr was submitted to represent ventralex st (device #1) and an emdr is submitted to represent ventralight st mesh (device #3).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 : device not returned.
Event or Problem Description
Per information provided by the patient's attorney: (b)(6) 2014 - patient was diagnosed with ventral incisional hernia at the robotic prostate surgery site and underwent open repair with ventralex st mesh (device #1).Per operative notes, " hernia sac identified.Therefore ventralex mesh (device #1) was placed and sutured¿.(b)(6) 2014 - patient underwent open recurrent ventral incisional hernia repair.Per operative notes, "the mesh was noted to be crumpled medially from the right, but was intact on the left.The mesh was then separated from the surrounding tissues was stretched back out into its normal position, reimplanted and stitches were placed ".(b)(6) 2015 - patient underwent open recurrent ventral incisional hernia repair with removal of the mesh and implanted with ventralight st mesh (device #2).Per operative notes, "the mesh had pulled out from one side completely.The mesh (device #1) was removed completely.We therefore selected ventralight st mesh (device #2) and placed into the abdominal defect¿.(b)(6) 2015 - patient underwent open repair of ventral incisional hernia with explant of ventralight st (device #2) and implanted with another ventralight st mesh (device #3).Per operative notes, "i found the previous mesh.It pulled out from one side completely and removed the previous mesh (device #2).I selected a ventralight st mesh (device #3) and sutured".Between (b)(6) 2015 to (b)(6) 2017, patient frequently visited hospital for post op follow up.During the visits, patient was diagnosed with ventral incisional hernia which did not bother, hence the patient was asked to continue the follow up visit and no treatment was provided.Attorney alleges that the patient had hernia recurrence, mesh migration and emotional injuries.It is also alleged that the patient underwent additional surgeries to repair the hernia, remove the mesh potential need for future surgery, permanent and severe scarring and disfigurement.

• Brand Name: VENTRALIGHT ST MESH
• Common Device Name: 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 17073416
• Report Number: 1213643-2023-092248
• Device Sequence Number: 20365859
• Product Code: FTL
• UDI-Device Identifier: 00801741031656
• UDI-Public: (01)00801741031656
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2023

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: 07/28/2016
• Device Catalogue Number: 5954680
• Device Lot Number: HUYG0527
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2014
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 96 KG