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

Catalog Number	5955600
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	11/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, about 4 years post-implant of the bard/davol ventralight st w/echo ps mesh, the patient was diagnosed with hernia recurrence and underwent an additional surgery for partial mesh removal and another ventralight st w/echo ps was placed.As reported, the ae has resolved.The clinician has assessed the patient¿s postoperative course as being "possibly" related to the study device and to the index 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 - partially explanted.
Event or Problem Description
Reported per clinical trial (b)(6): on (b)(6) 2014: subject patient underwent a robotic assisted first time recurrent midline hernia repair procedure during which a bard/davol ventralight st with echo ps was implanted using unspecified sutures.Skin closure was achieved using sutures and adhesive skin closure.The patient was discharged to home on (b)(6) 2014.On (b)(6) 2018: subject patient was presented with bulge and discomfort.On (b)(6) 2018: ct scan confirmed recurrent ventral incisional hernia.On (b)(6) 2018: subject patient underwent an reoperation for hernia recurrence and during the procedure, the mesh was partially removed (35%) and another ventralight st w/echo ps was implanted.The subject patient was discharged to home on (b)(6) 2018.Per the study clinician, the reported adverse event has been assessed as severe 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.

• Brand Name: VENTRALIGHT ST W/ ECHO
• 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: 14489665
• Report Number: 1213643-2022-00313
• Device Sequence Number: 5372838
• Product Code: FTL
• UDI-Device Identifier: 00801741031731
• UDI-Public: (01)00801741031731
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• 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: 03/28/2016
• Device Catalogue Number: 5955600
• Device Lot Number: HUYC0581
• 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: 05/24/2022
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 128 KG