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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hematoma (1884); Occlusion (1984); Thrombosis (2100); Claudication (2550); Vascular Dissection (3160)

Event Type  Injury  

Manufacturer Narrative

Questions were sent to the author of the article.He replied that the information requested was not easily accessible and that he would not be sending any information.The study concluded that (b)(6) is technically feasible and may offer an alternative to open surgery for complex aortoiliac occlusive disease.Associated file: 1219977-2017-00009.

Event Description

Received an article titled: initial experience with covered endovascular reconstruction of the aortic bifurcation in conjunction with chimney grafts published in the journal of endovascular therapy, 24(1), 19-24.The article discussed the feasibility of the covered endovascular repair of the aortic bifurcation (cerab) technique in conjunction with chimney grafts in aortic side branches for complex aortoiliac occlusive disease.Per the article, procedural complications included adverse events associated with the procedure and follow up.

• Brand Name: ATRIUM ADVANTA V12 COVERED STENT
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin rn, ccrn-k ; 40 continental blvd; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 6294199
• MDR Text Key: 66284556
• Report Number: 1219977-2017-00008
• Device Sequence Number: 1
• Product Code: NIN
• 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: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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