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

Catalog Number	5954124
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	07/12/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported per clinical trial (b)(4): (b)(6) 2013 - subject patient underwent a first time recurrent right flank open hernia repair using a bard/davol ventralight st mesh, fixated using a sorbafix fixation device and sutures.The fascia was completely closed by running stitches and full skin closure was achieved using staples.The subject patient was discharged from the hospital on (b)(6) 2013.(b)(6) 2016 - during a physical exam, the subject patient was diagnosed with right lumbar hernia.Patient was given time to lose weight.(b)(6) 2017 - ct scan performed hernia (10 cm width).(b)(6) 2017 - subject patient underwent hybrid surgery (open and robotic) wherein a non bard/davol onlay mesh was placed and the recurrent right ventral incisional hernia (15 x 15 cm) was repaired.Per the study clinician, the reported adverse event has been assessed as moderate in severity, possibly related to the study device and to the index procedure.The outcome for this ae is reported as recovered/resolved.
Additional Manufacturer Narrative
As reported, about 3.5 years post-implant of the ventralight st mesh, the patient was diagnosed with hernia recurrence and underwent surgical repair.As reported, the ae is resolved.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and 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 instructions-for-use supplied with the device lists hernia recurrence as a possible complication.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.Not returned - remains implanted.

• 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: 14438228
• Report Number: 1213643-2022-00239
• Device Sequence Number: 5151863
• Product Code: FTL
• UDI-Device Identifier: 00801741031601
• UDI-Public: (01)00801741031601
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 05/10/2022

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: 08/28/2014
• Device Catalogue Number: 5954124
• Device Lot Number: HUWH0489
• 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: 05/19/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 121 KG