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 Code	Erosion (1750)
Date of Event	04/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient underwent hiatal hernia repair on (b)(6) 2024 with the implant of a phasix st mesh.Reportedly, the mesh was placed with 3 mm of space between the esophagus and mesh.As reported 4 weeks post implant, the mesh eroded into the esophagus resulting in the need for an esophagectomy.As reported, the patient had been compromised, with an unknown cause or condition, prior to the implant procedure and was intubated.
Additional Manufacturer Narrative
As reported, the phasix st mesh eroded into the patient's esophagus.Based on the information provided, no conclusions can be made as to the degree to which the implant may have caused or contributed to the postoperative complication.The warning section of the instructions-for-use, supplied with the device, states, ¿for hiatal hernia repair, the use of phasix st mesh circumferentially around the esophagus is not recommended.The adverse reactions section states, ¿possible complications in hiatal hernia repair may include esophageal erosion.Review of manufacturing records confirms product was manufactured to specification.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.

• 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: 19215595
• Report Number: 1213643-2024-00218
• Device Sequence Number: 20859490
• Product Code: OWT
• UDI-Device Identifier: 00801741095337
• UDI-Public: (01)00801741095337
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2024

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: 04/28/2026
• Device Catalogue Number: 1200710
• Device Lot Number: HUHS1546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2023
• 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 Sex: Unknown