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

Catalog Number	1201520
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	08/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, approximately 1 year post-implant of the phasix st mesh, the patient was diagnosed with laxity around opening, and hernia recurrence and underwent surgical intervention for repair.The clinician has assessed the laxity as being ¿possibly¿ related to the study device and hernia recurrence as "not related" to the study device; however, based on the information provided, no conclusion can be made.Hernia recurrence is a known inherent risk of hernia repair surgery.The instructions-for-use supplied with the device lists hernia recurrence as a possible complication.This mdr represents the ae of laxity/hernia recurrence.Another mdr was submitted to represent the ae of exposed mesh.Not returned - remains implanted.
Event or Problem Description
Reported per clinical trial (b)(4): (b)(6) 2016 - subject patient underwent an open multiple recurrent ventral subxiphoid/epigastric hernia repair procedure using a bard/davol phasix st mesh placed in underlay fashion fixated with sutures.Full skin closure was achieved using staples and adhesive skin closure.The subject patient was discharged to home on (b)(6) 2016.(b)(6) 2017 - subject patient was diagnosed with mesh exposure which was sharply debrided at bedside.The surrounding area was too thin for sutures, the patient was advised to pack the wound with moist-to-dry dressings and follow up in 6-12 months.Per the study clinician, the reported adverse event has been assessed as mild in severity, possibly related to the study device and definitely related to the procedure.The outcome for this ae is reported as resolved.(b)(6) 2017 - subject patient presented with laxity around opening with no signs of hernia recurrence.(b)(6) 2018 - surgeon was unable to determine if the cause of laxity was diastasis or the patient¿s underlay repair of asymptomatic reducible ventral hernia.Per the study clinician, the reported adverse event has been assessed as mild in severity, possibly related to the study device and possibly related to the procedure.The outcome for this ae is reported as not recovered/not resolved.(b)(6) 2019 - subject patient was diagnosed with hernia recurrence using ct imaging.(b)(6) 2020 - subject patient underwent surgical intervention for hernia repair.The patient was discharged on (b)(6) 2020.Per the study clinician, the reported adverse event has been assessed as moderate in severity, not related to the study device and not related to the procedure.The outcome for this ae is reported as resolved.

• Brand Name: PHASIX ST 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: 14496576
• Report Number: 1213643-2022-00335
• Device Sequence Number: 5875023
• Product Code: OWT
• UDI-Device Identifier: 00801741095351
• UDI-Public: (01)00801741095351
• 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: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2022

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: 04/28/2017
• Device Catalogue Number: 1201520
• Device Lot Number: HUAR0135
• 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: 05/25/2022
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 93 KG