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

Model Number 85364

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Death (1802); Vascular Dissection (3160)

Event Date 04/25/2018

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted upon the receipt of the device sample and the completion of the investigation into this event.

Event Description

The doctor had to recover the balloon with a cut out of the a.Femoralis communis.Thereby dissected this vessel and had to become supported with a graft.The patient had a lot of blood preservations because the doctor couldn't clamp a.Iliaca externa.It was too short for this.Patient died following procedure.

Manufacturer Narrative

Based on the inspection of the returned catheter and the device history records review atrium medical cannot conclude that the balloon separation was a fault of the design or manufacture of the device.It is possible that the balloon was not allowed to deflate fully prior to withdrawing the balloon back through the introducer sheath.Clinical evaluation: aortoiliac occlusive disease is the blockage of the aorta, the main blood vessel in the body, or the iliac arteries.The iliac arteries are the branches that the aorta divides into around the level of the belly button to provide blood to the legs and the organs in the pelvis.This blockage is typically caused by a buildup of plaque and/or calcification within the walls of the blood vessels.Angioplasty is a procedure to open narrowed or blocked arteries.Angioplasty and stent placement are two ways to open blocked peripheral arteries.The advanta v12 covered stent system is indicated for restoring and improving the patency of the iliac and renal arteries.A stent can become dislodged if the vessel has calcification or severe disease, if the vessel has not been properly pre-dilated, if the stent or sheath has not been sized correctly or if the physician uses force to advance or withdraw the catheter.Arterial dissection occurs when a small tear forms in the innermost lining of the arterial wall (known as the tunica intima).Blood is then able to enter the space between the inner and outer layers of the vessel, causing narrowing (stenosis) or complete occlusion.Arterial dissection is an uncommon but well recognized complication of angiography, and usually resolves with compression of some form to the site but may require surgical intervention.During the procedure the arterial lumen is initially cannulated with a wire that is inserted through the sheath.The delivery catheter is advanced over the wire into the target lesion.Arterial dissection is usually a result of injury caused by the technique of the clinician or by advancing a wire forcefully.In a patient with vascular disease the veins and arteries are diseased and probably fragile and friable.Blood carries oxygen and nutrients to the tissues and organs and removes waste products.It is made up of several main components, including red blood cells, white blood cells, platelets, and plasma.Red blood cells carry and release oxygen throughout the body.White blood cells are part of your immune system and help fight infection.Platelets help the blood form clots, which stops bleeding.There are approximately 4 l to 5 l of blood in the body.Losing large amounts of blood quickly can lead to serious complications or death.Severe blood loss is usually treated with a transfusion or transfusion alternatives such as medications.Although all types of blood loss may cause complications, it is the large and rapid blood losses that occur during surgery and trauma that are most likely to cause severe complications or death.The amount of blood loss that may lead to complications depends on the individual person.It is affected by factors such as body size and the presence of certain health conditions (e.G., anemia).The instructions for use (ifu) state that potential adverse effects include, but may not be limited to bleeding, inadequate implantation or intimal trauma, dissection or rupture of the vessel, hemodynamic deterioration and migration.

• Brand Name: ADVANTA V12
• 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: 7499899
• MDR Text Key: 107777585
• Report Number: 3011175548-2018-00470
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• 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,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2020
• Device Model Number: 85364
• Device Catalogue Number: 85364
• Device Lot Number: 420083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 05/30/2018
• Date Device Manufactured: 09/21/2017
• 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): Death
• Patient Age: 77 YR