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

Catalog Number	1191530
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	03/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per clinical trial dvl-he-018: on (b)(6) 2023, the subject patient underwent primary laparotomy-colectomy procedure during which a phasix mesh (device 1) was trimmed and placed in onlay fashion using sorbafix fixation device (device 2).The patient was discharged to home on (b)(6) 2023.On (b)(6) 2023, patient had pain and underwent ct scan which revealed 3.5x3.5 cm hernia.On (b)(6) 2023, the patient underwent a robotic assisted recurrent hernia repair procedure.It was found the previously placed phasix mesh migrated alleging the sorbafix fasteners had failed to hold the implant in place.The phasix (approx.90%) was removed/explanted.A permanent synthetic mesh was used to treat the hernia.The adverse events as reported regarding the mesh device have been assessed per the clinician as severe in severity.The reported adverse event does not meet the definition of uade (unanticipated adverse device effect).
Additional Manufacturer Narrative
The patient was experienced hernia with implant migration post implant of phasix mesh.Based on the information provided, the mesh was found to be intact, and states the fixation device fasteners had failed to hold the mesh in its intended position.It cannot be determined why the fixation did not hold at this time.Review of manufacturing records for the phasix mesh confirms product was manufactured to specification.Lot number was not provided for the sorbafix and a manufacturing review could not be performed.This mdr represents the phasix mesh (device 1).An additional mdr was submitted to represent the sorbafix fixation (device 2).Hernia recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reactions section of the instructions-for-use, supplied with the device, as a possible complication.

• Brand Name: PHASIX 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: 17085266
• Report Number: 1213643-2023-00226
• Device Sequence Number: 12284012
• Product Code: OOD
• UDI-Device Identifier: 00801741107610
• UDI-Public: (01)00801741107610
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Study,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2023

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: 08/28/2023
• Device Catalogue Number: 1191530
• Device Lot Number: HUFW0401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2021
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 123 KG