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)
Health Effect - Clinical Codes	Adhesion(s) (1695); Inflammation (1932); Scar Tissue (2060); Hernia (2240)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2012 - patient was diagnosed with multiple ventral hernia thereby underwent open repair with the implant of bard flat mesh (device #1).Per operative notes, ¿multiple hernia sacs were connected into one large hernia.Partial omentectomy was performed.The hernia sacs were resected and the edges freshened back and anchored with sutures.Adhesiolysis had been performed.A bard flat mesh (device #1) was sewn to anterior abdominal wall as a buttress using interrupted sutures.¿ (b)(6) 2012 - patient was diagnosed with infected seroma thereby underwent incision and drainage of abdominal wall and vac placement.(b)(6) 2016 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the implant of ventralight st mesh (device #2).Per operative notes, ¿fibrotic tissue had invaginated into flat mesh(device #1).There was bowel within two hernia sacs present along the midline.The hernia sacs were excised.The second hernia sac in the epigastrium was excised, ventralight st mesh(device #2) was placed, extended above and below both hernias and sutured.¿ (b)(6) 2016 - patient was diagnosed with infected seroma thereby underwent incision and drainage of abdominal wall.On (b)(6) 2016 - patient underwent partial removal of redundant hernia mesh (device #2) from wound.(note, no operative notes were provided in medical records) (b)(6) 2017 - patient was diagnosed with reducible ventral hernia thereby underwent laparoscopic repair with the implant of ventralight st mesh (device #3).Per operative notes, "there was multiple adhesions and multiple small hernias of the midline abdominal and right lateral mid abdominal wall were taken down.The bowel was more densely adhered, were able to take down all the bowel.A piece of ventralight st mesh(device #3) was used for repair and secured with suture." (note, there was no mention/ visualization of ventralight st mesh (device #2) and flat mesh (device #1) in operative notes) (b)(6) 2018 - patient was diagnosed with multiple recurrent incarcerated incisional hernia thereby underwent open repair of implant of bard soft mesh (device #4) and removal of bard flat mesh (device #1) and ventralight st mesh (device #3).Per operative notes, ¿dense adhesion and omentum to the anterior abdominal wall were taken down.The intraabdominal mesh(device #1) was removed.The myofascial advancement flap was performed on both side.A soft mesh(device #4) was placed to reinforce abdominal wall with sutures.Lot of scar tissue associated with prior onlay mesh and wound infections.The mesh (device #3) was removed from the subcutaneous space.¿ (note: there was no mention/visualization of ventralight st mesh (device #2) in operative notes) attorney alleges that the patient had adhesions, mesh migration, mesh shrinkage, infection, pain & suffering, seroma, hernia recurrence, bowel obstruction, loss of domain and emotional injuries.
Additional Manufacturer Narrative
Based on the additional information received, no conclusions can be made.Per medical records review, about 1 year post implant of ventralight st mesh, patient was diagnosed with hernia recurrence, adhesions, inflammation, scar tissue thereby underwent removal of mesh.The instructions-for-use supplied with the device lists hernia recurrence, adhesions and inflammation as possible complications.Note, the manufacturing date (15-oct-2016) is considered to be a best estimate.This emdr represents the bard/davol ventralight st mesh (device #3).Additional supplemental emdrs were submitted to represent the bard flat mesh (device #1) and bard/davol ventralight st mesh (device #2).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.

• 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: 20817980
• Report Number: 1213643-2024-094831
• Device Sequence Number: 15362784
• Product Code: FTL
• UDI-Device Identifier: 00801741031656
• UDI-Public: (01)00801741031656(17)181028(10)HUAX0083
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2024

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: 5954680
• Device Lot Number: HUAX0083
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2016
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 96 KG