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

Device Problem Insufficient Information (3190)

Patient Problems Loss Of Pulse (2562); No Code Available (3191)

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, this technique allows early reperfusion of the ischemic extremity upon institution of the cardiopulmonary bypass circuit with concomitant emergent repair of the ascending aorta.

Event Description

Received an article titled "a method of treating patients with acute type a aortic dissection and lower extremity malperfusion." the article was to describe a technique, where acute limb ischemia is concomitantly managed with the replacement of the ascending aort/hemiarch or aortic arch.In addition to axillary artery cannulation, the ischemic lower extremity is perfused through a polytetrafluoroethylene (ptfe) graft, which is connected to the cardiopulmonary bypass circuit.Per the article adverse events included: two patients underwent fem to fem bypass due to pulse deficits coming off bypass.Three patients had four compartment fasciotomies of the affected lower extremity.

• 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: 7341893
• MDR Text Key: 102513838
• Report Number: 3011175548-2018-00258
• 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
• Reporter Occupation: Physician
• 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
• Is the Reporter a Health Professional?: Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention