MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION I-CAST COVERED STENT; STENT, RENAL

Model Number	85453
Health Effect - Clinical Code	Collapse (2416)
Date of Event	07/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On completion of the investigation a final report will be submitted.Not available for return.
Event or Problem Description
It was reported that 409 days post endovascular aneurysm repair it was noted that the right renal stent was occluded.No intervention has occurred to date and there are no current plans for information.
Additional Manufacturer Narrative
Additional information: a 2, a 3, a 4.And b 7.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
It was reported that 409 days post endovascular aneurysm repair one of the two, or both of the stents placed in the right renal artery had occluded.The patient involved was enrolled in the zenith p-b ranch pivotal study conducted by cook, inc.No intervention has occurred to date and there are no current plans for intervention.The correspondence with the clinical manager from cook medical indicated the following ¿the site noted tortuous iliac arteries bilaterally and that the case was technically difficult due to the angulation of the aortic neck and orientation or the fenestrations and the visceral artery orifices".It was also noted on the 12-month imaging that the right renal stent was noted to be occluded.The notes also indicate that two 6mm x 22mm stents were placed in the right renal artery.The clinical manager did state that the kink was noted in the right renal artery stent, which was attributed to the acute angulation of the aortic neck.If the stent had kinked this would explain why the stent was occluded.The clinical manager also indicates that the kink was attributed to the acute angulation of the aortic neck.Other reasons for a kink of a stent would be if the fenestration of the endograft was not aligned properly with the renal artery.There is also a possibility that the endograft migrated slightly.This would also kink the stent.A review of the device history records indicates that this production lot of icast covered stents and relevant sub assembly device history records passed all quality and performance requirements prior to being released.A review of the incoming inspection of the raw stent was also conducted.There were no anomalies or non-conformances noted during this review.Based on the information provided the occlusion of the stent is due to the tight angulation of the aortic neck as described in the correspondence with the clinical manager.There is no evidence to conclude that the icast covered stent was the cause of the reported complaint.H3 other text : not available for return.

• Brand Name: I-CAST COVERED STENT
• Common Device Name: STENT, RENAL
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 10342198
• Report Number: 3011175548-2020-00981
• Device Sequence Number: 19687277
• Product Code: NIN
• UDI-Device Identifier: 00650862854534
• UDI-Public: 00650862854534
• Combination Product (Y/N): N
• PMA/510(K) Number: K080514
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2020

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: Health Professional
• Device Expiration Date: 11/11/2020
• Device Model Number: 85453
• Device Catalogue Number: 85453
• Device Lot Number: 424075
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 08/17/2020; 01/05/2021
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 08/20/2020; 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 89 YR
• Patient Weight: 83