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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis (2100); Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

A complaint investigation was not able to be performed as no product code, lot number, or sample was provided.Per the article sound judgment is required to determine whether or not the patient requires closure of their cardiac defect, weighing the risks and benefits of cardiothoracic intervention in this patient subpopulation with the likelihood of future thromboembolic events and need for additional access related interventions.

Event Description

Received an article titled "paradoxical embolus following percutaneous thrombectomy of hemodialysis reliable outflow graft." the article was to illustrate an extremely rare but potentially devastating complication of one of these procedures: cerebrovascular insult due to paradoxical embolism in the setting of a patent foramen ovale.Per the article adverse events included: thrombosis and stenosis.

• 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: 7340981
• MDR Text Key: 102458574
• Report Number: 3011175548-2018-00260
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2018
• 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): Required Intervention