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

Catalog Number UNKAA110

Device Problem Insufficient Information (3190)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Type  Injury  

Manufacturer Narrative

A definitive conclusion cannot be made.However, based on the comments from the consulting surgeon the issue that presented (dysphagia) does not appear to be device related.As commented by the consulting surgeon the, "dysphagia is most likely from crural closure, fundoplication and perhaps some scarring from the esophagitis rather than related to the mesh".A lot number was not provided, without a lot number a review of the manufacturing records is not possible.The adverse reaction section of the instructions-for-use states, "possible complications in hiatal hernia repair may include esophageal erosion and dysphagia related to crural fibrosis." as reported the mesh was wrapped 360 degrees around the esophagus.For hiatal hernia repair, the instructions-for-use states "the use of phasix¿ st mesh circumferentially around the esophagus is not recommended." should additional information be obtained, a supplemental emdr will be submitted.The information provided by bard 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 bard.Remains implanted.

Event Description

It was reported that the patient underwent the repair of a hiatal hernia and was implanted with a phasix st mesh.The surgeon reports postoperatively the patient developed dysphagia.The surgeon requested a surgeon to surgeon consult.Following the consult the consulting surgeon reported the following: the patient has a history of espohagitis.The procedure was a laparoscopic nissen fundoplication.The surgeon used 52 bougie for the fundoplication.The surgeon wrapped the phasix st mesh 360 degrees around the esophagus.Postoperatively the patient developed dysphagia and gi put a stint in.When the stent was removed and patient was noted to have an ulcer.After dilatation a perforation developed.No mesh was seen in the lumen, as such there did not appear to be any mesh erosion.The consulting surgeon states, " i think the stent against an esophagus with prior esophagitis and up against the crural closure and fundoplication likely led to pressure necrosis of the esophagus.I don¿t think this is a mesh issue.Recommended against 360 degree wrap of mesh around esophagus in future.Also discussed that dysphagia most likely from crural closure, fundoplication and perhaps some scarring from the esophagitis rather than related to the mesh".

• Brand Name: PHASIX ST MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 7937793
• MDR Text Key: 122798386
• Report Number: 1213643-2018-03431
• Device Sequence Number: 1
• Product Code: OWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention