MAUDE Adverse Event Report: ATRIUM MEDICAL ADVANTA VS GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Sepsis (2067)

Event Type  Death  

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number, or sample was provided.Per the study, axillary to iliac/femoral vein bypass can salvage functioning ipsilateral fistula threatened by occluded upper central vein and relieve their upper limb obstructive venous symptoms.

Event Description

Received a study titled "extra-anatomical veno-venous surgical bypass for central vein occlusion." the study was to describe an extra-anatomical venous bypass surgical procedure performed to maintain vascular access and reduce the symptoms of swelling of the ipsilateral upper limb, neck and face in patients that underwent bypass between november 2009 and april 2013.Per the article patient deaths during follow-up included cardiac related complications and patient sepsis.

• Brand Name: ADVANTA VS GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7332555
• MDR Text Key: 102180799
• Report Number: 3011175548-2018-00239
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2018

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/12/2018
• 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): Death