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

Catalog Number	1200710
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Erosion (1750); Dysphagia/ Odynophagia (1815)
Date of Event	04/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the bard/davol phasix st mesh was used for esophageal hiatal hernia repair and about one year post-implant, the patient experienced dysphagia and erosion and underwent subsequent surgical intervention for removal of the mesh.Based on the information provided to date, no conclusion can be made.The warning section of the instructions-for-use, (ifu) states "for hiatal hernia repair, the use of phasix¿ st mesh circumferentially around the esophagus is not recommended." additionally, the adverse reaction section of the ifu states ¿possible complications in hiatal hernia repair may include esophageal erosion and dysphagia related to crural fibrosis." to date, this is the only reported complaint from this manufacturing lot.Should additional information be provided, a supplemental mdr will be submitted.
Event or Problem Description
As reported, a (b)(6) year old female patient underwent robotically assisted hiatal hernia repair with nissen fundoplication procedure on (b)(6) 2020 with the implant of a bard/davol phasix st mesh.It was reported that the surgeon may have cut a keyhole in the mesh and wrapped it around the crus, during implant.The patient underwent mesh removal surgery on (b)(6) 2021, with takedown of nissen due to dysphagia.Mesh was noted to be eroding into posterior aspect of esophagus.Esophagogastroduodenoscopy (egd) done during the procedure showed mesh inside lumen of esophagus and pieces of mesh were removed endoscopically.The esophagus was repaired.The patient is doing well.

• 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
• MDR Report Key: 11811344
• Report Number: 1213643-2021-20111
• Device Sequence Number: 17080714
• Product Code: OWT
• UDI-Device Identifier: 00801741095337
• UDI-Public: (01)00801741095337
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/23/2021

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: 11/28/2021
• Device Catalogue Number: 1200710
• Device Lot Number: HUDX0527
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 05/12/2021
• 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: 53 YR