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

Catalog Number	1201520
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	03/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information, the cause of the patient's hernia recurrence cannot be determined.Recurrence is a known inherent risk of hernia repair surgery.Regarding hernia recurrence the warning section of the instructions-for-use states, "to prevent recurrences when repairing hernias, phasix st mesh must be large enough to provide sufficient overlap beyond the margins of the repair/primary closure.Careful attention to mesh fixation placement and spacing will help prevent excessive tension or gap formation between the mesh and fascial tissue.No action has been taken at this time.If additional information is provided, a supplemental emdr will be submitted.Remains implanted.
Event or Problem Description
It was reported to davol that a patient who is part of a clinical study experienced a hernia recurrence.(b)(6) 2017 - the subject patient underwent a laparoscopic umbilical repair of hernia using an intra-abdominal approach, with implant of the phasix st mesh.As reported, the phasix st mesh was positioned so that its edges extend beyond the margins of the defect by at least 5cm.Both mechanical and suture fixation were used to secure the mesh.(b)(6) 2019 - the subject patient underwent a physical exam in which a bulge at the umbilicus was identified.(b)(6) 2019 - the subject patient underwent a ct scan that confirmed the bulge to be a hernia recurrence.This hernia recurrence has been assessed per the clinician as mild in severity and "possibly related" to the study device and "possibly related" to the index procedure.No action has been taken at this time, however, as reported, the subject will be scheduling an appointment for surgery in the near future.

• Brand Name: PHASIX ST
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8515355
• Report Number: 1213643-2019-02968
• Device Sequence Number: 16525124
• Product Code: OWT
• UDI-Device Identifier: 00801741095351
• UDI-Public: (01)00801741095351
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other,study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2019

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: 01/28/2019
• Device Catalogue Number: 1201520
• Device Lot Number: HUAZ1860
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 04/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR