MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ADVANTA V12 COVERED STENT; STENT, ILIAC

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Hematoma (1884); Ischemia (1942); Perforation (2001); Stenosis (2263); Blood Loss (2597); Thromboembolism (2654)

Event Type  Injury  

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number or sample was provided.Per the study, the anatomic configuration of branches in b/f-evar of taaas and pararenal abdominal aortic aneurysms changes over time.The change in angle of branches and the bridging stent influences the likelihood of stenosis and occlusion.Follow-up of b/f-evar should include computed tomography angiography measurements of aortic diameter, endograft migration, target vessel stent length, and angulation to detect disconnection, stenosis, and occlusion.Device not returned.

Event Description

Received an article titled geometric changes over time in bridging stents after branched and fenestrated endovascular repair for thoracoabdominal aneurysm.Purpose: the objective of this study was to assess long-term durability of bridging stents in branched and combined branched and fenestrated endovascular aneurysm repair (b/f-evar) for thoracoabdominal aortic aneurysm (taaa) and pararenal abdominal aortic aneurysm.Method: a retrospective database analysis was performed of patients treated by b/f-evar for taaa.Computed tomography angiography images were analyzed to assess patency, bridging stent angulation and migration, aneurysm diameter, and migration of the endograft.Conclusion: the anatomic configuration of branches in b/f-evar of taaas and pararenal abdominal aortic aneurysms changes over time.The change in angle of branches and the bridging stent influences the likelihood of stenosis and occlusion.Follow-up of b/f-evar should include computed tomography angiography measurements of aortic diameter, endograft migration, target vessel stent length, and angulation to detect disconnection, stenosis, and occlusion.Per the article adverse events included: perforation, inadequate implantation, bleeding, hemodynamic deterioration, ischemia, hematoma, thromboembolic episode and restenosis.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: lynda mclaughlin ; 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 9622401
• MDR Text Key: 179301831
• Report Number: 3011175548-2020-00122
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• 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: 01/20/2020
• 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: 1
• Patient Outcome(s): Required Intervention