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

Model Number	85455
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
Home patient called to report adverse events that occurred after placement of an icast stent in her left common carotid artery.Follow up computed tomography scan showed migration of the graft with partial collapse of the stent.
Additional Manufacturer Narrative
Engineering summary: a full review of the catheter lot history records for the device in question was performed.The records indicate that this lot of catheters passed atriums final lot qualification testing.This inspection requires that the catheter lot must pass the following: ability of the stent and delivery system to be passed through the labeled introducer sheath.Ability to deploy the stent at nominal pressure (8atm).Ability to withdraw the deflated balloon catheter back through the labeled introducer sheath ability of the delivery system to withstand 5 inflate/deflate cycles at the rated burst pressure (12atm) without leaks or failures.Balloon burst testing.The balloon must burst over the rated burst pressure specified on the label (12atm).Result: all quality inspection samples passed this final inspection without any non-conformances noted during the final lot qualification testing.Conclusion: based on the successful lot qualification test data, atrium medical a division of the maquet getinge group company can find no fault with the lot of stent delivery systems in question.Clinical evaluation: obstruction can be caused by anatomical process, infectious process or mechanical process including the mal-positioning of a stent.Carotid artery obstruction interrupts the flow of blood that delivers oxygen to your brain and head.A stent can become an obstruction in a vessel if it is not positioned properly prior to deployment or if the product chosen is not designed specifically for the anatomic location targeted.
Additional Manufacturer Narrative
Medwatch submitted to link mw5071899 to 1219977-2016-00250.Statements in mw5071899 were not made by manufacturer as reported.
Event or Problem Description
Medwatch received: mw5071899.

• Brand Name: ATRIUM ICAST COVERED STENT
• Common Device Name: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• MDR Report Key: 6157579
• Report Number: 1219977-2016-00250
• Device Sequence Number: 19011836
• Product Code: JCT
• UDI-Device Identifier: 00650862854558
• UDI-Public: 00650862854558
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2016

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
• Operator of Device: Physician
• Device Expiration Date: 03/31/2018
• Device Model Number: 85455
• Device Catalogue Number: 85455
• Device Lot Number: 222731
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/05/2016
• Supplement Date Received by Manufacturer: Not provided; 09/15/2017
• Initial Report FDA Received Date: 12/09/2016
• Supplement Report FDA Received Date: 01/10/2017; 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR