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

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

Patient Problems Embolism (1829); Hematoma (1884); Hemorrhage/Bleeding (1888); Ischemia (1942); Occlusion (1984); Pain (1994); Renal Failure (2041); Thrombus (2101); Vascular Dissection (3160)

Event Type  Injury  

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number or sample was provided.The article concluded early term data suggest that physician modified fenestrated thoracic endografts can be used to safely and effectively treat taaa in patients at high risk of open repair.[(b)(4)].

Event Description

Article: sweet, m.(2015).Endovascular treatment of thoracoabdominal aortic aneurysm using physician modified endografts.Journal of vascular surgery, 1160-1167.Purpose: to report an initial experience with physician modified thoracic endografts for endovascular treatment of thoracoabdominal aortic aneurysm (taaa) per the article adverse events included ischemic events, pain, hemorrhage, dissection, occlusion, embolic events, hematoma, thrombus and renal failure.

• Brand Name: ADVANTA SST 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: 7942822
• MDR Text Key: 123061306
• Report Number: 3011175548-2018-01119
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K010517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2018
• Initial Date FDA Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention