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

Catalog Number	5950010
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hernia (2240)
Date of Event	11/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided by patient's attorney: (b)(6) 2013 - patient was diagnosed with incisional hernia thereby underwent laparoscopic repair with the implant of sepramesh ip (device #1).Per operative notes, ¿upon initial inspection of the hernia, it appeared to be an incisional hernia in the epigastric location.There was some omentum within the hernia defect, and this was taken down.A sepramesh ip (device #1) was placed with tacker and sutured." (b)(6) 2016 - patient visited hospital for left and right lower quadrant abdominal pain and underwent ct imaging.(b)(6) 2016 - patient was diagnosed with incarcerated recurrent incisional hernia, peritoneal adhesions thereby underwent laparoscopic repair with the implant of ventrio st (device #2).Per operative notes, ¿adhesiolysis was performed by taking down omentum where it was stuck to the anterior abdominal wall, both in the area of previously placed mesh (device #1) as well as just to the actual peritoneum itself.The hernia defect was identified and separated from the patient¿s previous mesh.A ventrio st (device #2) was placed into the abdomen with tacker.The patients previously placed mesh (device #1) appeared to be in good position.¿ (b)(6) 2017 - patient visited hospital for abdominal pain.(b)(6) 2017 - patient had ongoing problem with hernia.(b)(6) 2017 - patient visited hospital for weak spots on stomach wall bilaterally and felt having hernias in 3 spots.Attorney alleges that the patient had adhesions, hernia recurrence, chronic constipation, hemorrhoids, bloating, gas and pain.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical record review, about 1 year 7 months post implant of ventrio st, patient was diagnosed with hernia recurrence, abdominal pain.The adverse reaction section of the instructions-for-use, supplied with the device identify hernia recurrence as a possible complication.This emdr represents ventrio st (device #2).An additional supplemental emdr was submitted to represent sepramesh ip (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.

• Brand Name: VENTRIO ST
• 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: 18509435
• Report Number: 1213643-2024-090063
• Device Sequence Number: 7948430
• Product Code: FTL
• UDI-Device Identifier: 00801741031502
• UDI-Public: (01)00801741031502
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2024

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: 06/28/2017
• Device Catalogue Number: 5950010
• Device Lot Number: HUZF1124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 01/13/2024
• 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: 37 YR
• Patient Sex: Female
• Patient Weight: 123 KG