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 Codes	Adhesion(s) (1695); Laceration(s) (1946)
Date of Event	11/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the st bioresorbable coating of the ventrio st mesh adhered to the mesocolon while being implanted by the surgeon.Additional information has been requested.As reported, the subject device is available for evaluation; however, has not been received, at this time.Based on the information available, no conclusion can be made as to the cause of the problem experienced.Review of manufacturing records shows product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in may, 2021.The instructions-for-use (ifu) supplied with the device lists adhesions as a possible complication.The warnings section of the ifu states "ensure proper orientation; the bioresorbable coated side of the prosthesis should be oriented against the bowel or sensitive organs.Do not place the polypropylene mesh side against the bowel.There may be a possibility for adhesion formation when the mesh is placed in direct contact with the bowel or viscera".If/when sample is received and evaluated and/or additional information is provided, a supplemental mdr will be submitted.
Event or Problem Description
As reported, during implant of the bard/davol ventrio st mesh, the adhesion barrier (st) side of the mesh adhered to the mesocolon.As reported, it was difficult to remove the mesh, resulting in tearing the mesocolon.This required hemostasis and the procedure was stopped to address the condition.It was reported that there was a risk of colon ischemia for the patient.
Additional Manufacturer Narrative
As reported, the st bioresorbable coating of the ventrio st mesh adhered to the mesocolon while being implanted by the surgeon.Additional information has been requested.As reported, the subject device is available for evaluation; however, has not been received, at this time.Based on the information available, no conclusion can be made as to the cause of the problem experienced.Review of manufacturing records shows product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of 40 units released for distribution in may, 2021.The instructions-for-use (ifu) supplied with the device lists adhesions as a possible complication.The warnings section of the ifu states "ensure proper orientation; the bioresorbable coated side of the prosthesis should be oriented against the bowel or sensitive organs.Do not place the polypropylene mesh side against the bowel.There may be a possibility for adhesion formation when the mesh is placed in direct contact with the bowel or viscera".Addendum: this is an addendum to the initial mdr submitted to document results of sample evaluation and findings.As received, there is tissue adhered on the coated side of the ventrio st.There were no manufacturing/material anomalies identified.Based on the event as reported and sample condition, the root cause was that the implant was placed into contact with mesocolon and tissue attached to the surface.It cannot be determined at this time if the st barrier was adequately hydrated or some dry areas were present.Why the mesocolon attached so quickly and tenaciously to the implant (dry or fully hydrated) cannot be determined at this time.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 : sample evaluated.
Event or Problem Description
As reported, during implant of the bard/davol ventrio st mesh, the adhesion barrier (st) side of the mesh adhered to the mesocolon.As reported, it was difficult to remove the mesh, resulting in tearing the mesocolon.This required hemostasis and the procedure was stopped to address the condition.It was reported that there was a risk of colon ischemia for the patient.Addendum per additional information: as reported, during a laparotomy procedure on 09-nov-2021, the ventrio st mesh was hydrated in saline, not folded and placed anatomically in the mesocolon which was clearly visible during placement of the mesh.As reported, the mesh was in contact with the mesocolon for a very little time.It was reported that another mesh was used to complete the procedure.

• 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: 12955105
• Report Number: 1213643-2021-20454
• Device Sequence Number: 4829976
• Product Code: FTL
• UDI-Device Identifier: 00801741031564
• UDI-Public: (01)00801741031564
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

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 Expiration Date: 03/28/2023
• Device Catalogue Number: 5950070
• Device Lot Number: HUFR0313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2021
• 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 Sex: Unknown