MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRIO ST; SURGICAL MESH

Catalog Number	5950070
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information obtained no conclusion can be made.Postoperative infection is a known inherent risk of surgery.The instructions-for-use (ifu) supplied with the device identifies infection as a possible complication.In regards to infection, the warnings 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." without a lot number, review of the manufacturing records cannot be conducted.Note, it is unclear how the splenic surgery relates to the mesh infection.Note, the date of event is estimated based on the information available.Note, we were unable to locate an english translation of the attached article/abstract.If/when additional information be provided, a supplemental emdr will be submitted.Not returned - mesh explanted.
Event or Problem Description
Per symposium presentation during hernia week 2020 tokyo - "three cases of mesh infection after abdominal wall hernia requiring mesh removal" the patient underwent a ventral incisional hernia repair procedure with implant of a bard/davol ventrio st mesh.About one month post-operative, the patient developed a mesh infection.The patient underwent surgery and the mesh was removed and direct suturing were performed early.The patient was reported to be doing well and discharged 10 days after the operation.As reported, there was no recurrence of infection.
Additional Manufacturer Narrative
Based on the information obtained no conclusion can be made.Postoperative infection is a known inherent risk of surgery.The instructions-for-use (ifu) supplied with the device identifies infection as a possible complication.In regards to infection, the warnings 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." without a lot number, review of the manufacturing records cannot be conducted.Note, it is unclear how the splenic surgery relates to the mesh infection.Note, the date of event is estimated based on the information available.Note, we were unable to locate an english translation of the attached article/abstract.If/when additional information be provided, a supplemental emdr will be submitted.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 - mesh explanted.
Event or Problem Description
Per symposium presentation during hernia week 2020 tokyo - "three cases of mesh infection after abdominal wall hernia requiring mesh removal" the patient underwent a ventral incisional hernia repair procedure with implant of a bard/davol ventrio st mesh.About one month post-operative, the patient developed a mesh infection.The patient underwent surgery and the mesh was removed and direct suturing were performed early.The patient was reported to be doing well and discharged 10 days after the operation.As reported, there was no recurrence of infection.

• Brand Name: VENTRIO ST
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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 ; 8005566756
• MDR Report Key: 12822186
• Report Number: 1213643-2021-20414
• Device Sequence Number: 17566993
• Product Code: FTL
• UDI-Device Identifier: 00801741031588
• UDI-Public: (01)00801741031588
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2021

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 Catalogue Number: 5950070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 11/19/2021
• 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: 63 YR
• Patient Sex: Female