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

Catalog Number	1200710
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Erosion (1750)
Date of Event	09/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusion can be made as to the degree to which the mesh implant may have caused or contributed to the patient outcome.A review of the manufacturing records was performed and found that the lot was manufactured to specification.There have been no other patient adverse events reported for this production lot of 320 units released for distribution in (b)(6) 2018.Adhesion and erosion are known inherent risks of surgery and are listed in the adverse reactions section of the instructions-for-use as possible complications.Should additional information be provided, a supplemental emdr will be submitted.Remains implanted.
Event or Problem Description
It was reported that on (b)(6) 2019 the patient underwent a robotic assisted hiatal hernia repair procedure with implant of a bard phasix st mesh.It is alleged that on (b)(6) 2019 the patient underwent a revision procedure of the hiatal hernia repair during which it was reported that the phasix st mesh was adhered and had eroded into the patient's esophagus.As reported, the surgeon did not remove any of the mesh and placed a g-tube as the patient cannot consume any food or drink by mouth.It is alleged that the patient will either have to keep the g-tube in place indefinitely or will have to remove some of the patient's esophagus.

• 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: 9142067
• Report Number: 1213643-2019-09584
• Device Sequence Number: 16817959
• Product Code: OWT
• UDI-Device Identifier: 00801741095337
• UDI-Public: (01)00801741095337
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/01/2019

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: 07/28/2020
• Device Catalogue Number: 1200710
• Device Lot Number: HUCS1962
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 10/01/2019
• 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: Disability
• Patient Age: 77 YR