MAUDE Adverse Event Report: ATRIUM MEDICAL ADVANTA V12 VASCULAR STENTS; STENT, ILLIAC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Rupture (2208)

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 that ec allows evar of varying complexity without the need for open surgical ilio-femoral conduits in patients with concomitant advanced iliac occlusive disease.(b)(4).

Event Description

Article received: asciutto, g.E.(2017).Endoconduits with "pave and crack" technique avoid open ilio-femoral conduits with sustainable mid-term results.European journal of vascular endovascular surgery, 472-479.Purpose: to evaluate the feasibility and mid-term outcomes of endoconduits (ec) with the ¿pave and crack¿ technique during endovascular aneurysm repair (evar) of varying complexity.Per the article adverse events included: type iia endoleaks r/t iatrogenic dissection; reintervention; thrombo-endarterectomy; unintentional coverage of a renal artery; hemorrhage of a renal artery; groin infections; rupture of thoraco-abdominal aneurysm; spinal cord ischaemia; re-occlusion.

• Brand Name: ADVANTA V12 VASCULAR STENTS
• Type of Device: STENT, ILLIAC
• 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: 7921908
• MDR Text Key: 122163931
• Report Number: 3011175548-2018-01079
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: SE
• 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: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2018
• 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: 09/14/2018
• 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: 1
• Patient Outcome(s): Required Intervention