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

Catalog Number	5950090
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Granuloma (1876); Hernia (2240); Fluid Discharge (2686)
Date of Event	11/07/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per additional information received: on (b)(6) 2017 - patient with incisional ventral hernia underwent repair with ventralex st mesh (device #1).Per the operative notes,¿ i opened the old incision and dissected the hernia sac.I put ventralex st mesh (device #1) and sutured." on (b)(6) 2017 - patient was diagnosed with cellulitis.On (b)(6) 2017 - patient developed seroma, fistula and infection around the mesh and underwent excision of mesh and primary fascial closure.Per the operative notes, " i make an opening in the old incision.There was a fistulous track from the mesh to the skin which was dissected.There was lot of scar tissue in the area and also granulation tissue that is infected in this area around the mesh.I pulled the mesh out." on (b)(6) 2017 - patient was diagnosed with recurrent ventral hernia and underwent laparoscopic repair with mesh.Per the operative notes," there were adhesions and ventral hernia.I opened a midline incision and dissected the hernia sac.Ventralight st mesh (device #2) was plaved underlay behind the muscle and sutured." on (b)(6) 2017 - patient developed abdominal pain.On (b)(6) 2017 - patient visited the hospital for abdominal pain and diagnosed with recurrent incisional hernia with possible infected seroma and underwent repair with ventrio st (device #3) and removal of old mesh (ventralight st) (device #2).Per the operative notes,¿ i took the old sutures, there was a seroma which was aspirated.Under the fascia, there was a hematoma that was evacuated.The old ventralight (st) mesh (device #2) was encountered which was starting to adhere and debrided a gelatinous coagulum on the mesh and removed the old mesh.After removing all the adhesions from another hernia, i then put mesh (ventrio st mesh) (device #3) and sutured." on (b)(6) 2017 - patient developed drainage from the umbilicus and underwent revision surgery for remove the umbilicus, infected granulation tissue and suture and wound vac placement.Attorney alleges that the patient had pain, hernia recurrence, seroma, emotional injuries, infection, three subsequent surgeries for recurrent ventral hernia and debridement of abdominal wall.
Additional Manufacturer Narrative
Based on the additional information received, no conclusions can be made.Per medical record review this patient with a history of hernia repairs had recurrent hernia and was repaired using a ventrio st.About 2 months post implant, patient was developed drainage from the umbilicus and underwent revision surgery for remove the umbilicus and suture removal and wound vac placement.The instructions-for-use supplied with the device lists hernia recurrence as a possible complications.This emdr represents the ventrio st (device #3).A supplemental emdr was submitted for the ventralex st(device #1) and additional emdr was submitted to represent the ventralight st (device #2).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 additional information received: (b)(6) 2017 - patient with incisional ventral hernia underwent repair with ventralex st mesh (device #1).Per the operative notes,¿ i opened the old incision and dissected the hernia sac.I put ventralex st mesh (device #1) and sutured." (b)(6) 2017 - patient was diagnosed with cellulitis.(b)(6) 2017 - patient developed seroma, fistula and infection around the mesh and underwent excision of mesh and primary fascial closure.Per the operative notes, " i make an opening in the old incision.There was a fistulous track from the mesh to the skin which was dissected.There was lot of scar tissue in the area and also granulation tissue that is infected in this area around the mesh.I pulled the mesh out." (b)(6) 2017 - patient was diagnosed with recurrent ventral hernia and underwent laparoscopic repair with mesh.Per the operative notes," there were adhesions and ventral hernia.I opened a midline incision and dissected the hernia sac.Ventralight st mesh (device #2) was plaved underlay behind the muscle and sutured." (b)(6) 2017 - patient developed abdominal pain.(b)(6) 2017 - patient visited the hospital for abdominal pain and diagnosed with recurrent incisional hernia with possible infected seroma and underwent repair with ventrio st (device #3) and removal of old mesh (ventralight st) (device #2).Per the operative notes,¿ i took the old sutures, there was a seroma which was aspirated.Under the fascia, there was a hematoma that was evacuated.The old ventralight (st) mesh (device #2) was encountered which was starting to adhere and debrided a gelatinous coagulum on the mesh and removed the old mesh.After removing all the adhesions from another hernia, i then put mesh (ventrio st mesh) (device #3) and sutured." (b)(6) 2017 - patient developed drainage from the umbilicus and underwent revision surgery for remove the umbilicus, infected granulation tissue and suture and wound vac placement.Attorney alleges that the patient had pain, hernia recurrence, seroma, emotional injuries, infection, three subsequent surgeries for recurrent ventral hernia and debridement of abdominal wall.
Additional Manufacturer Narrative
Based on the additional information received, no conclusions can be made.Per medical record review this patient with a history of hernia repairs had recurrent hernia and was repaired using a ventrio st.About 2 months post implant, patient was developed drainage from the umbilicus and underwent revision surgery for remove the umbilicus and suture removal and wound vac placement.The instructions-for-use supplied with the device lists hernia recurrence as a possible complications.Addendum: h11: this supplemental emdr was submitted to correct the implant date.This supplemental emdr represents the ventrio st (device #3).A supplemental emdr was previously submitted for the ventralex st(device #1) and additional emdr was previously submitted to represent the ventralight st (device #2).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.

• 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: 16994578
• Report Number: 1213643-2023-092099
• Device Sequence Number: 15213735
• Product Code: FTL
• UDI-Device Identifier: 00801741031588
• UDI-Public: (01)00801741031588
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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: 09/28/2018
• Device Catalogue Number: 5950090
• Device Lot Number: HUAV0122
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2016
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 108 KG