MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ATRIUM ICAST COVERED STENTS; PTFE COVERED STENT

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

Patient Problem Embolus (1830)

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 systematic review indicates that both fenestrated and chimney techniques are attractive options for jaas treatment with encouraging outcomes.Related mdrs: 1219977-2016-00080, 1219977-2016-00082, 1219977-2016-00083, 1219977-2016-00084, 1219977-2016-00085, 1219977-2016-00086, 1219977-2016-00087, 1219977-2016-00088, 1219977-2016-00090.

Event Description

Received an article titled "fenestrated and chimney technique for juxtarenal aortic aneurysm: a systematic review and pooled data analysis published in the scientific report.The article consisted of a comparison of nine fenestrated endovascular aortic repair cohort studies (f-evar) including 542 patients and eight chimney endovascular aortic repair (ch-evar) including 158 patients from articles published between 2005 through 2013.Per the article, 1 patient experienced an embolic event.

• Brand Name: ATRIUM ICAST COVERED STENTS
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH
• Manufacturer Contact: theresa morin ; 40 continental blvd; merrimack, NH 03054 ; 6038645237
• MDR Report Key: 5660453
• MDR Text Key: 45346073
• Report Number: 1219977-2016-00081
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/26/2016
• Initial Date FDA Received: 05/17/2016
• 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