MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST MESH; SURGICAL MESH

Catalog Number	5954113
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hernia (2240)
Date of Event	11/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, about five months post implant of ventralight st mesh, the patient presented with abdominal pain "related to hernia recurrence" and about 7 months later, the patient was diagnosed with hernia recurrence and underwent subsequent surgical intervention for mesh explant.The clinician has assessed the patient¿s abdominal pain as being ¿possibly¿ related to the study device and to the procedure; the hernia recurrence as being "not related" to the study device and possibly related to the procedure; however, based on the information provided, no conclusion can be made.Hernia recurrence is a known inherent risk of hernia repair surgery.The adverse reactions section of the instructions-for-use, supplied with the device lists hernia recurrence as a possible complication.Not returned - mesh explanted.
Event or Problem Description
Reported per clinical trial dvl-he-020: (b)(6) 2018 - subject patient underwent multiple recurrent open midline umbilical hernia repair, during which a bard/davol ventralight st mesh was placed in underlay fashion in an intra-peritoneal region using non-bard/davol mechanical fixation and sutures.Fascia and full skin closure was achieved with sutures.The patient was discharged on (b)(6)2018.(b)(6) 2018 - the patient presented with acute abdominal pain related to hernia recurrence.Per the study clinician, the reported adverse event (abdominal pain) has been assessed as mild in severity, possibly related to the study device and possibly related to the index procedure.The outcome for this ae is reported as recovered/resolved.(b)(6) 2019 - subject patient was diagnosed with hernia recurrence during a physical exam.(b)(6) 2019 - subject patient underwent surgery for mesh removal and implanted with another bard/davol ventralight st mesh.The patient was discharged on (b)(6) 2018.Per the study clinician, the reported adverse event (hernia recurrence) has been assessed as severe in severity, not related to the study device and definitely related to the index procedure.The outcome for this ae is reported as recovered/resolved.

• Brand Name: VENTRALIGHT ST MESH
• 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: 14495195
• Report Number: 1213643-2022-00332
• Device Sequence Number: 12221525
• Product Code: FTL
• UDI-Device Identifier: 00801741031595
• UDI-Public: (01)00801741031595
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2022

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: 01/28/2020
• Device Catalogue Number: 5954113
• Device Lot Number: HUCN0285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/25/2022
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 121 KG