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

Catalog Number	1200015
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	04/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusion can be made.While the clinician has stated the issue to be "definitely related" to the device, based on the information provided we are unable to determine to what extent, if any, the phasix st mesh may have caused or contributed to the patient's hernia recurrence.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.A review of the manufacturing records was performed and found that the lot was manufactured to specification.If additional information is provided, a supplemental emdr will be submitted.Note: the information provided by bard 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 bard.Remains implanted.
Event or Problem Description
It was reported to davol that a patient who is part of a clinical study (phasix st clinical study dvl-he-017) experienced a hernia recurrence.On (b)(6) 2016 - the subject patient underwent laparoscopic repair of an umbilical hernia with implant of the phasix st mesh.Intra-abdominal technique was used.Mechanical fixation was used to fixate the mesh.On (b)(6) 2018 - the subject patient was diagnosed with a hernia recurrence via ct scan.Hernia noted to be reducible this recurrence is assessed by the clinician to be moderate in severity and not a serious adverse event, definitely related to the study device and not related to the index procedure.As reported intervention is required, however a revision date has not been scheduled at this time.

• Brand Name: PHASIX ST MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7848124
• Report Number: 1213643-2018-03028
• Device Sequence Number: 1053025
• Product Code: OWT
• UDI-Device Identifier: 00801741095290
• UDI-Public: (01)00801741095290
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

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: 06/28/2018
• Device Catalogue Number: 1200015
• Device Lot Number: HUAU0502
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 09/05/2018
• 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: 60 YR