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	Hernia (2240)
Date of Event	12/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient developed a hernia recurrence post-implant of phasix st mesh and underwent esophagram to confirm the hernia recurrence.As reported, the ae is not resolved.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and to the procedure, 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.Not returned - remains implanted.
Event or Problem Description
Reported per clinical trial (b)(6): on (b)(6) 2017 - the subject patient underwent laparoscopic repair of first time recurrent paraesophageal hiatal hernia along with toupet fundoplication and esophagogastroduodenoscopy (egd) procedures.A phasix st mesh was placed in underlay fashion intra-peritoneally, fixated using vicryl sutures at 4 fixation points.Full skin closure was achieved using sutures and adhesive skin closure.The patient was discharged to home on (b)(6) 2017.On (b)(6) 2017 - the patient was diagnosed with paraesophageal hiatal hernia (peh) recurrence following an esophagram scan.On (b)(6) 2018 - during physical exam paraesophageal hiatal hernia (peh) recurrence was noted.The ae is clinically assessed to be possibly related to the study device and possibly related to the procedure.This has been assessed as a non-serious adverse event of mild severity, and has not resolved, there has been no action taken.The reported adverse event does not meet the definition of an sae (serious adverse event).

• 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: 14434650
• Report Number: 1213643-2022-00233
• Device Sequence Number: 5579082
• Product Code: OWT
• UDI-Device Identifier: 00801741095337
• UDI-Public: (01)00801741095337
• 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: 2017
• 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): 05/09/2022

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: 01/28/2019
• Device Catalogue Number: 1200710
• Device Lot Number: HUBN0723
• 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: 05/19/2022
• 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: 87 YR
• Patient Sex: Male
• Patient Weight: 80 KG