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); Hernia (2240)
Date of Event	08/10/2017
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 year post implant of ventrio st, patient was diagnosed with hernia recurrence and adhesions thereby underwent repair with mesh removal.The instructions-for-use supplied with the device lists hernia recurrence and adhesions as possible complications.Review of manufacturing records confirms product was manufactured to specification.This emdr represents ventrio st (device #5).Additional supplemental emdr's were submitted to represent mesh ¿ composix kugel (device #1), bard flat mesh (device #2) and ventrio mesh (device #4).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.
Event or Problem Description
Per information provided: on (b)(6) 2010 - patient was diagnosed with ventral hernia thereby underwent open repair with implant of composix kugel mesh (device #1).Per operative notes, ¿there were multiple defects.All the defects were combined into one defect and a composix kugel mesh (device #1) was sewn in place with sutures.¿ on (b)(6) 2013 - patient was diagnosed with recurrent ventral hernia and bilateral inguinal hernias thereby underwent open repair with the implant of bard flat mesh (right - device #2 & left ¿ device #3) for bilateral inguinal hernias, ventrio mesh (device #4) for recurrent ventral hernia and explant of composix kugel mesh (device #1).Per operative notes, ¿the direct inguinal hernia was identified in the right groin and a bard flat mesh (right- device #2) was sewn in place with sutures.Then, direct hernia identified in the left inguinal region was repaired using bard flat mesh (left ¿ device #3) and sutured.The previous mesh (device #1) was encountered, where the mesh had torn from the fascia.The old mesh was removed and replaced with a ventrio mesh (device #4) and sewn in place with sutures.¿ on (b)(6) 2016 - patient was diagnosed with recurrent incisional hernia in the upper abdomen thereby underwent open repair with the implant of ventrio st mesh (device #5) and explant of ventrio mesh (device #4).Per operative notes, ¿the previous mesh (device #4) was removed and a ventrio st mesh (device #5) was sewn in place with sutured.¿ on (b)(6) 2017 - patient was diagnosed with adhesions, recurrent incisional hernia thereby underwent open repair with the implant of phasix st mesh (device #6) and explant of ventrio st mesh (device #5).Per operative notes, ¿the old mesh (device #4) was encountered and was dissected.The sutures were then cut and removed; the mesh was dissected free from underlying adhesions completely.There was a hole in the peritoneum close to the rib cage.A phasix st mesh (device #6) was placed into the space and sutured.¿ attorney alleges that the patient had adhesions, pain and hernia recurrence.It is also alleged that the prior mesh had tom from the abdominal wall in two areas, unincorporated mesh and mesh removal.

• 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: 20850778
• Report Number: 1213643-2024-094836
• Device Sequence Number: 3928505
• Product Code: FTL
• UDI-Device Identifier: 00801741031540
• UDI-Public: (01)00801741031540(17)180428(10)HUAQ1058
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2024

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: 04/28/2018
• Device Catalogue Number: 5950050
• Device Lot Number: HUAQ1058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2016
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 115 KG