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

Catalog Number	0010214
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	06/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient developed a hernia recurrence approximately 3 years post-implant and underwent surgical intervention.The reported condition was clinically assessed to be definitely related to the study device and indeterminate in relation to the index procedure; however, based on the information provided, we are unable to determine to what extent, if any, the ventrio mesh may have caused or contributed to the patient's postoperative hernia recurrence.As reported, hernia recurrence had resolved.Hernia recurrence is a known inherent risk of hernia repair surgery and is listed in the instructions-for-use (ifu) supplied the device as a possible complication.Should additional information be provided a supplemental emdr will be submitted.Not returned - remains implanted.
Event or Problem Description
It was reported to davol that a patient who is part of a clinical study experienced hernia recurrence.On (b)(6) 2015: the subject male patient underwent repair of an primary ventral epigastric hernia using ventrio, large circle, 4.5 cm with eptfe mesh, performed in an open fashion.The mesh was placed pre-peritoneally.The mesh was sutured in position using non-bard/davol sutures.Interrupted sutures were used to close the fascia.The skin was completely closed using sutures.The subject patient was also administered with prophylactic antibiotics.The patient was discharged to home.On (b)(6) 2018: the subject patient was diagnosed with an epigastric recurrent hernia of length 9cm and width 10cm.The hernia recurrence was assessed by the clinician as moderate in severity and not a serious adverse event (sae) and required reoperation and had resolved.The ae has been assessed per clinician as definitely related to the study device and indeterminate in relation to the index procedure.
Additional Manufacturer Narrative
As reported, the patient developed a hernia recurrence approximately 3 years post-implant and underwent surgical intervention.The reported condition was clinically assessed to be definitely related to the study device and indeterminate in relation to the index procedure; however, based on the information provided, we are unable to determine to what extent, if any, the ventrio mesh may have caused or contributed to the patient's postoperative hernia recurrence.As reported, hernia recurrence had resolved.Hernia recurrence is a known inherent risk of hernia repair surgery and is listed in the instructions-for-use (ifu) supplied the device as a possible complication.Addendum: this is addendum to the initial emdr submitted.This supplemental emdr is being submitted to make a correction to d4 - expiry date.A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to specification.Should 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.Not returned - remains implanted.
Event or Problem Description
It was reported to davol that a patient who is part of a clinical study experienced hernia recurrence.(b)(6) 2015: the subject male patient underwent repair of an primary ventral epigastric hernia using ventrio, large circle, 4.5 cm with eptfe mesh, performed in an open fashion.The mesh was placed pre-peritoneally.The mesh was sutured in position using non-bard/davol sutures.Interrupted sutures were used to close the fascia.The skin was completely closed using sutures.The subject patient was also administered with prophylactic antibiotics.The patient was discharged to home.(b)(6) 2018: the subject patient was diagnosed with an epigastric recurrent hernia of length 9cm and width 10cm.The hernia recurrence was assessed by the clinician as moderate in severity and not a serious adverse event (sae) and required reoperation and had resolved.The ae has been assessed per clinician as definitely related to the study device and indeterminate in relation to the index procedure.

• Brand Name: VENTRIO MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10642270
• Report Number: 1213643-2020-09043
• Device Sequence Number: 3287700
• Product Code: FTL
• UDI-Device Identifier: 00801741016417
• UDI-Public: (01)00801741016417
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other,study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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: 08/28/2015
• Device Catalogue Number: 0010214
• Device Lot Number: HUWH0662
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR