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

Catalog Number	5950050
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Bowel Perforation (2668)
Date of Event	02/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the additional information received, no conclusions can be made.Per medical records review, about 1 week post implant of ventrio st mesh, patient was diagnosed with infection, adhesions and bowel perforation thereby underwent removal of mesh.The instructions-for-use supplied with the device lists adhesions, infection and bowel perforation as possible complications.The warning section of the ifu states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the prosthesis.An unresolved infection may require removal of the prosthesis".This emdr represents ventrio st (device #2).An additional supplemental emdr has been submitted to represents composix mesh e/x (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.
Event or Problem Description
Per information provided: (b)(6) 2006 - patient was diagnosed with epigastric hernia thereby underwent laparoscopic repair with the implant of composix e/x mesh (device#1).Per operative notes, ¿hernia was identified in the epigastric region and the dissection was carried out.A composix e/x mesh (device#1) was placed using staples.¿ (b)(6) 2016 - patient was diagnosed with recurrent epigastric hernia thereby underwent open repair with removal of old composix e/x mesh (device #1).Per operative notes, ¿the old mesh (device#1) was encountered, and it was curled up.This was dissected and removed.The omental adhesions were lysed, and the hernia was repaired by using sutures.¿ (b)(6) 2016, (b)(6) 2017 - patient was diagnosed with small bowel obstruction, incarcerated epigastric hernia and adhesions thereby underwent repair.(b)(6) 2018 - patient was diagnosed with recurrent epigastric hernia thereby underwent open repair with the implant of ventrio st mesh (device #2).Per operative notes, ¿the previous sutures were gaped into the scar tissues, and there was a large hernia.A ventrio st mesh (device #2) was placed into the abdomen using sutures and tackers.¿ (b)(6) 2018 - patient was diagnosed with infected mesh and bowel perforation, thereby underwent removal of ventrio mesh (device #2).Per operative notes, ¿there was some turbid fluid leaking from the wound.The ventrio mesh (device #2) appeared to be infected, and it was removed.The abdominal cavity had extensive adhesions, and it was lysed.A loop of small bowel was glued together and there was a leak from this area.¿ attorney alleged that the patient had abscess, adhesions, bowel obstruction, bowel perforation, bowel removal, infection, mesh migration, mesh shrinkage, pain, hernia recurrence and emotional injuries.It was also alleged for mesh removal and removal of infected mass.

• 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: 20479319
• Report Number: 1213643-2024-094761
• Device Sequence Number: 20874436
• Product Code: FTL
• UDI-Device Identifier: 00801741031540
• UDI-Public: (01)00801741031540(17)190528(10)HUBS0143
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 10/18/2024

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: 05/28/2019
• Device Catalogue Number: 5950050
• Device Lot Number: HUBS0143
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/18/2024
• 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: Life Threatening; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male