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 Blood Loss (2597); Pseudoaneurysm (2605)

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 was a clinical presentation of a difficult case.[(b)(4)].Device not returned.

Event Description

Received an article titled: hybrid endovascular exclusion of a bleeding innominate artery pseudoaneurysm in a patient with no open surgical options.Purpose: to present the case of a patient who developed a bleeding innominate artery after primary lung cancer resection complicated by an infected chest wound.Method: a case study.Per the article adverse events included blood loss and pseudoaneurysm.

• 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: 9639110
• MDR Text Key: 176685660
• Report Number: 3011175548-2020-00179
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• 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: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2020
• 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
• Patient Age: 58 YR