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

Catalog Number	5954124
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Abscess (1690); Fistula (1862); Hematoma (1884); Seroma (2069)
Date of Event	04/13/2017
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 few months post implant of ventralight st mesh, patient was diagnosed with fistula, abscess, seroma, hematoma and abdominal pain.The instructions-for-use supplied with the device lists fistula, seroma, hematoma and pain as possible complications.This emdr represents the ventralight st mesh (device #4).An additional supplemental emdr was submitted to represent the ventrio mesh (device #1) and additional emdr's were submitted to represent the ventralight st mesh (device #2) and mesh ¿ ventralex (device #3).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
Addendum per additional information provided: (b)(6) 2015 - patient was diagnosed with incarcerated ventral hernia thereby underwent open repair with the implant of ventrio mesh (device #1).Per operative notes, ¿the adhesions were removed and the small bowel and right colon placed back into the peritoneal cavity.The old mesh was removed and a gore-tex patch (ventrio mesh - device #1) was used.The mesh was placed intraperitoneal and then secured with sutures attaching it to the mesh anteriorly and circumferentially.¿ (b)(6) 2016 - patient was diagnosed with recurrent incarcerated incisional hernia and spigelian hernia thereby underwent open repair with implant of ventralight st mesh (device #2).Per operative notes, ¿left lower quadrant lysis of adhesions were accomplished.Dissection was carried superiorly, the adhesions from the previous mesh were quite large and revealed the recurrent hernia superior to the mesh.A piece of ventralight st mesh (device #2) placed in elliptical fashion and tacked.¿ (b)(6) 2016 - patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent open repair with implant of ventralex mesh (device #3) and partial removal of ventrio mesh (device #1).Per operative notes, ¿the hernia sac was encountered, the mesh had separated from the fascia on left lateral side of previous hernia repair that was dissected (device #1).The hernia sac was opened, it appeared that the medial side was densely adherent and there was no sign of recurrent hernia there.A large ventralex mesh (device #3) placed in the gap peritoneally in order to repair the gap between the previously placed mesh.The medial side was sutured to the previously placed mesh and the lateral side was sutured to the fascia using sutures.¿ (b)(6) 2016 - patient underwent removal of infected mesh (device #2 & device #3).(note, operative notes were not provided in the medical records).(b)(6) 2017 - patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent open repair with implant of ventralight st mesh (device #4) and explant of ventrio mesh (device #1).Per operative notes, ¿the hernia sac was excised.There was 5 different pieces of previously placed mesh was seen and they were grown well in peritoneal surface.It was easy to excise and we did.Lysis of adhesions within peritoneal cavity and anterior separation of abdominal components was performed.A ventralight mesh (device #4) placed within peritoneal cavity and tacked." (b)(6) 2017 - patient was diagnosed with abdominal pain, hemorrhage with edema, abscess, hematoma, serosanguinous drainage and tissue granulation.Attorney alleges that the patient had abscess, adhesions, pain, bowel obstruction, bowel removal, hernia recurrence, pain, seroma, fistulae, infection and emotional injuries.It is also alleged that the patient had at least 4 surgical revisions/procedures after the ventrio mesh placement in 2015, ventralight st placement and ventralex placement in both in 2016.The damage caused by the bard mesh products is extensive and resulted in complete abdominal wall reconstruction.

• Brand Name: VENTRALIGHT ST MESH
• 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: 20243652
• Report Number: 1213643-2024-094694
• Device Sequence Number: 12590930
• Product Code: FTL
• UDI-Device Identifier: 00801741031601
• UDI-Public: (01)00801741031601
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• 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
• Report Date (Section B): 09/18/2024

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 Catalogue Number: 5954124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/18/2024
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 122 KG