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

Catalog Number	5955810
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932); Scar Tissue (2060); Seroma (2069); Hernia (2240)
Date of Event	06/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per the medical records review, post implant of ventralight st w/ echo, the obese patient was diagnosed with recurrent hernia, granuloma, hemorrhage, inflammation, adhesions, seroma, scar tissue thereby underwent repair with the removal of mesh.The instructions-for-use supplied with the device identify adhesions, seroma, inflammation and hernia recurrence as possible complications.This emdr represents ventralight st w/ echo (device #2).An additional supplemental emdr was submitted to represent the ventralex st (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.
Event or Problem Description
Per information provided by the attorney: (b)(6) 2015 - patient was diagnosed with incarcerated incisional hernia thereby underwent laparoscopic repair with the implant of ventralex st mesh (device #1).Per operative notes, "there was a hernia to the right of midline in the lower abdomen.The hernia was measured and it was at the edge of the prior biological mesh, which was well incorporated.A large ventralex st mesh (device #1) was placed into the abdominal cavity and tacked.¿ (b)(6) 2016 to (b)(6) 2016 - patient frequently visited hospital for right quadrant lower abdominal pain.(b)(6) 2016 - patient was diagnosed with pain and adhesions thereby underwent repair with mesh removal.Per operative notes, "mesh prosthesis was then incised, there were severe intestinal and omental adhesions which were dissected from the mesh prosthesis and mesh (device #1) was then explanted with sharp dissection.Upon removal of one staple, there was some clear fluid leak.This was possibly from a seroma although it was concern of possibility of a staple being in the wall of the bladder." (b)(6) 2016 - patient visited hospital for abdominal pain.(b)(6) 2017 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant of ventralight st w/ echo ps (device #2).Per operative notes, "severe intra-abdominal adhesions were dissected.A quite large hernia defect was then covered with ventralight st mesh with echo positioning system (device #2) and was tacked." (b)(6) 2018 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the removal of ventralight st w/ echo ps (device #2).Per operative notes, "the multiple adhesions were lysed.In order to free up abdominal wall and previously placed mesh a portion of omentum, bowel were resected.In the right lower quadrant, mesh (device #2) has failed to incorporate into the abdominal wall and mesh forming the hernia sac were excised.There was a chronic seroma between mesh and the right lower abdominal wall which was removed including seroma capsule.There was moderate amount of scar tissue.A synthetic mesh was placed and sutured.¿ attorney alleges that patient had adhesions, hernia recurrence, infection, pain and emotional injuries.It is also alleged that patient underwent subsequent surgeries to repair recurrent hernia and clean out infected wounds.It is alleged that the patient then developed post surgical wound that had to be cleaned out on (b)(6) 2018 and (b)(6) 2018, later patient underwent laparoscopic recurrent hernia repair and lysis of adhesions on (b)(6) 2019.

• 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: 17975054
• Report Number: 1213643-2023-094206
• Device Sequence Number: 2491700
• Product Code: FTL
• UDI-Device Identifier: 00801741031786
• UDI-Public: (01)00801741031786
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• 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): 10/20/2023

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: 06/28/2018
• Device Catalogue Number: 5955810
• Device Lot Number: HUAT2306
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 10/20/2023
• 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: 40 YR
• Patient Sex: Female
• Patient Weight: 89 KG