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

Catalog Number	5955460
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Hernia (2240)
Date of Event	12/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about seven months post implant, patient was diagnosed with abdominal pain, adhesions and hernia recurrence thereby underwent repair with excision of mesh.The instructions-for-use supplied with the device lists hernia recurrence and adhesions as possible complications.This emdr represents the ventralight st w/ echo (device #3).Additional supplemental emdrs were submitted to represent the composix mesh e/x (device #1) and mesh ¿ ventralex (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.
Event or Problem Description
Per information provided by patient's attorney: (b)(6) 2009 - patient was diagnosed with complex ventral hernia and underwent laparoscopic hernioplasty with implant of composix e/x (device #1) and ventralex mesh (device #2).Per operative notes, "noted 3 separate small fascial defects at umbilicus, supraumbilicus space and one just to the right of supraumbilicus space.Then the abdominal fascial defects was taken down.A composix e/x (device #1) mesh was placed into the peritoneal cavity with polypropylene side to the abdominal facia.A small ventralex mesh (device #2) was placed intracorporeally to cover the fascial defect and tacked." (b)(6) 2016 - patient underwent robotic ventral incisional hernia repair with placement of ventralight st mesh with echo ps (device #3) and explant of existing hernia meshes (device #1 & #2).Per operative notes, ¿the upper abdominal portion of the mesh (device #2) was fairly well incorporated however there were multiple omental adhesions and were lysed.Along the lower aspect of the mesh, there were several loops of small bowel adherent to the mesh (device #1).After lysis of adhesions, the recurrent hernia was located in the inferior aspect of the mesh where it was pulled away from the abdominal wall and the mesh was excised.The mesh (device #2) was placed in the left upper quadrant to be removed at the completion of the procedure.After the mesh had been removed, the hernia defect was then repaired with ventralight st mesh with the echo positioning system (device #3) placed inside the abdominal cavity.¿ (b)(6) 2016 - patient was diagnosed with abdominal pain, possible recurrent ventral hernia and abdominal wall dysfunction thereby underwent repair with removal of existing ventralight st w/ echo mesh (device #3) and bilateral myocutaneous muscle advancement.Per operative notes, "there were adhesions from the omentum, colon to the anterior abdominal wall and to the mesh (device #3).They were lysed and removed the abdominal mesh.A bard soft mesh (device #4) was cut to an appropriate size and then placed within the retrorectus space with sutures as well as glue.¿ attorney alleges that the patient had pain, adhesions, hernia recurrence, and emotional injuries.

• Brand Name: VENTRALIGHT ST W/ ECHO
• 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: 18146683
• Report Number: 1213643-2023-094567
• Device Sequence Number: 20710884
• Product Code: FTL
• UDI-Device Identifier: 00801741031724
• UDI-Public: (01)00801741031724
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2023

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: 02/28/2018
• Device Catalogue Number: 5955460
• Device Lot Number: HUAN1650
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 43 YR
• Patient Sex: Male