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 Code	Hernia (2240)
Date of Event	11/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per additional information provided: (b)(6) 2008 - patient was diagnosed with incisional hernia thereby underwent laparoscopic repair with the implant of ventralex mesh (device #1).Per operative notes, ¿a large hernia sac at the colostomy site on the left and several small midline defects above were noted, a synthetic mesh was placed, the superior right side of mesh pulled away slightly from the area and a round mesh ventralex mesh (device #1) was placed and sutured.¿ (b)(6) 2009 - patient was diagnosed with recurrent incisional hernia thereby underwent open hernia repair with the implant of sepramesh ip (device #2) and removal of ventralex mesh (device #1).Per operative notes, ¿a hernia was identified and circumferentially dissected down to the fascia and the sac was removed.A large water of omentum was incarcerated in the hernia was reduced.The left upper portion of prior mesh was separated and the recurrence noted.Another hernia defect was noted above the previous mesh (device #1) in midline.The most portion of the previous mesh (device #1) was removed.Some portions of the mesh were densely adherent to healthy muscle were left intact.Adhesions were taken down.A sepramesh ip (device #2) was placed intraperitoneally intact circumferentially far from the fascial edges and sutured.¿ (b)(6) 2016 - patient admitted hospital for intra-abdominal abscess and colonic perforation with sepsis.(b)(6) 2016 - patient was diagnosed with infected mesh (device #2) thereby underwent removal of mesh, diverting ileostomy and abdominal washout.Per operative notes, ¿the mesh from previous repair was immediately encountered with very dense adhesion from the small bowel to the mesh noted.The previously placed mesh was freed where it was poorly incorporated and removed as whole (device #2).The abscess cavity was identified at base of the descending colon mesentery.Drain was placed.¿ (b)(6) 2018 - patient was diagnosed with recurrent incisional hernia thereby underwent robotic assisted laparoscopic hernia repair with the implant of ventralight st mesh (device #3).Per operative notes, ¿lysis of adhesions was performed.The hernia defect was located and cleared.The two large defects were sutured and a double-sided mesh (ventralight st ¿ device #3) was placed over and sutured.¿ (b)(6) 2018 - patient was diagnosed with complex recurrent incisional hernia thereby underwent robotic assisted laparoscopic repair with the implant of synthetic mesh.Per operative notes, ¿extensive lysis of adhesions and component separation was performed.The defects were closed and sutured.A macro porous light weight mesh above the dissected fascia and sutured.¿ (notes, there was no visualization of previously placed mesh) attorney alleges that the patient had abscess, adhesions, bowel obstruction, bowel perforation, pain, hernia recurrence, ileostomy reversal and emotional injuries.
Additional Manufacturer Narrative
Based on the additional information received, no conclusions can be made.Per medical records review, about 6 months post implant of ventralight st mesh, patient was diagnosed with hernia recurrence thereby underwent repair.The instructions-for-use supplied with the device lists hernia recurrence as a possible complication.This emdr represents the ventralight st mesh (device #3).An additional supplemental emdr was submitted to represent the sepramesh ip (device #2) and an emdr was submitted to represent mesh - ventralex (device #1).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: not returned.

• 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: 20564686
• Report Number: 1213643-2024-094778
• Device Sequence Number: 7569462
• Product Code: FTL
• UDI-Device Identifier: 00801741031656
• UDI-Public: (01)00801741031656(17)220228(10)HUCN1774
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2024

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: 02/28/2022
• Device Catalogue Number: 5954680
• Device Lot Number: HUCN1774
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 10/30/2024
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 97 KG