MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ICAST COVERED STENT SYSTEM; PROSTHESIS, TRACHEAL, EXPANDABLE

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Renal Failure (2041); Blood Loss (2597); Vascular Dissection (3160)

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, implantation of f/b-evar in patient with failed previous evar is a challenging undertaking that can be performed safely with a high technical success and low reintervention rates.[(b)(4)].Device not returned.

Event Description

Received an article titled technical approach and outcomes of failed infrarenal endovascular aneurysm repairs rescued with fenestrated and branched endografts.Purpose: to report the outcomes and discuss the approach to rescuing previously failed infrarenal endovascular aneurysm repairs with fenestrated/branched endografts (f/b-evar).Method: a retrospective analysis of prospectively collected data of consecutive patients with failed evar rescued with f/b-evar at our institution from november 2013 to march 2019 was conducted.Adverse events included: renal failure, dialysis, hypotension, compartment syndrome, endoleaks and dissection.

• Brand Name: ICAST COVERED STENT SYSTEM
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• 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: 9622393
• MDR Text Key: 176079007
• Report Number: 3011175548-2020-00124
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• 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: 01/17/2020
• 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