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 Codes	Abdominal Pain (1685); Hernia (2240)
Date of Event	07/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Based on the available information, no conclusion can be made.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 experienced a hernia recurrence.On (b)(6) 2016: the subject patient underwent an umbilical hernia repair with implant of the phasix st mesh.On (b)(6) 2018: the patient was diagnosed with a hernia recurrence.This hernia recurrence was confirmed via ultrasound and has been assessed by the clinician as mild in severity, definitely related to the study device and not related to the procedure.It is reported the subject patient will undergo a reoperation.
Additional Manufacturer Narrative
This is an addendum to the initial emdr to document that the patient has undergone a revision procedure to repair the recurrent hernia.Based on this additional information the initial determination remains the same, no conclusion can be made.If additional information is provided, a supplemental emdr will be submitted.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.
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) 2016: the subject patient underwent an umbilical hernia repair with implant of the phasix st mesh.(b)(6) 2018: the patient was diagnosed with a hernia recurrence.This hernia recurrence was confirmed via ultrasound and has been assessed by the clinician as mild in severity, definitely related to the study device and not related to the procedure.It is reported the subject patient will undergo a reoperation.Addendum: on (b)(6) 2018 the subject patient underwent laparoscopic repair of the hernia recurrence with an unspecified permanent synthetic mesh.As reported, the phasix st mesh was not explanted during this procedure.

• 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: 7643270
• Report Number: 1213643-2018-02244
• Device Sequence Number: 16772386
• Product Code: OWT
• UDI-Device Identifier: 00801741095290
• UDI-Public: (01)00801741095290
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: other,study
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2019

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: 06/28/2018
• Device Catalogue Number: 1200015
• Device Lot Number: HUAU0502
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 02/15/2019
• 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: 79 YR