MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION STENTS I-CAST; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number 85453

Device Problems Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aneurysm (1708)

Event Date 09/15/2017

Event Type  Injury  

Manufacturer Narrative

The follow-up report will be submitted upon completion of the investigation.

Event Description

Event: on (b)(6) 2017, the post procedure computed tomography (ct ) scan was performed.Site analysis and core lab of the ct revealed patency of all devices.There was no separation of components, migration, or device integrity issues noted.A type iii endoleak was noted at the right renal stent and the p-branch device.On the same day, the patient underwent percutaneous balloon angioplasty and placement of a 6 mm x 38 mm atrium icast renal stent (covered) in the right renal artery.The intervention was considered successful.

Event Description

N/a.

Manufacturer Narrative

This complaint is associated with the zenith® p branch® pivotal study, which is a clinical trial approved by fda to study the safety and effectiveness of the zenith® p branch® endovascular graft in combination with the atrium icast¿ covered stents in the treatment of abdominal aortic aneurysms.Clinicaltrials.Gov identifier: (b)(4).Based on the details of the complaint and the images provided from the case, it would appear that there is a possibility that the stent was not flared enough at the ostium of the stent where it passes through the fenestration ring of the endograft and into the right renal artery.The icast coved stent extends into the aorta significantly but may also be related to the angles of the images provided.There was also a significant waist as the stent passes through the fenestration ring of the endograft.Based on the images provided the complaint can be confirmed.Based on this investigation including the review of the device history records there is no indication the icast covered stent was the cause of the complaint.In this regard the complaint cannot be confirmed to have been caused by the icast covered stent and the root cause likely attributed to the operational context.A review of applicable device history records was conducted.There were no related non conformances noted during this build of devices or indications of any manufacturing defect that could have contributed to the issue.After review of the details of the complaint provided, as well as review of the published clinical literature as cited in the complaint¿s medical assessment that highlights the possible risks and complications known to occur following placement of icast¿ balloon expandable covered stent in the renal artery through a fenestration of the zenith® p-branch® graft, one can infer the unfortunate injuries suffered by this patient are potentially multifactorial and getinge¿s icast¿ balloon expandable covered stent was not the only attributing factor.The factors likely include but are not limited to, loss of apposition or disconnect between icast stent and the zenith® p-branch® graft, surgical technique, such as inadequate flaring of the icast stent.Based on the details of the complaint and investigation conducted, it is likely that the complaint is an artifact of the operational context.H3 other text : device not available for return.

• Brand Name: STENTS I-CAST
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 12566565
• MDR Text Key: 274419920
• Report Number: 3011175548-2021-01015
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854534
• UDI-Public: 00650862854534
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2020
• Device Model Number: 85453
• Device Catalogue Number: 85453
• Device Lot Number: 415013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/10/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 10 X 2 CM BALLOON (MODEL # 22077346).
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 52 KG