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

Model Number	85445
Health Effect - Clinical Codes	Aneurysm (1708); Calcium Deposits/Calcification (1758)
Date of Event	09/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
Report received stated on 01-sep-2021 the patient was diagnosed with an occlusion of the sma (within the stent).On (b)(6) 2021, there was an unsuccessful secondary intervention attempt.The site noted, ¿attempt was made to cannulate the superior mesenteric artery stent, but this was not possible.It was apparent that the aortic stent fenestration had migrated more caudal from the stent and the fabric completely covered the orifice of the superior mesenteric artery stent.Further attempts at recanalization were discontinued.¿.
Additional Manufacturer Narrative
Additional information received.
Event or Problem Description
Additional information received on 28-feb-2022 stated that there was a proximal migration of the sma stent (covered) after the principal investigator reviewed the (unsuccessful) secondary intervention angiogram and the three-year post-procedure computed tomography angiography (cta) for a submitted query.
Additional 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).The review of the complaint details indicates that the icast covered stent had migrated proximally however upon investigation had noted that the p branch graft that lined the aorta had migrated covering the sma.This migration of the p branch graft would explain the proximal migration of the icast covered stent in the sma as the icast covered stent is placed and positioned through the fenestration of the p¿branch graft.This movement would certainly either move the icast covered stent or block it in this case.As there were no images provided the complaint cannot be confirmed.Based on the provided details it would appear the migration of the p branch graft was the cause of the noted events.There is no indication that the icast covered stent product was deficient.In this regard the complaint cannot be confirmed 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 superior mesenteric artery (sma) 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, aortic stent graft migration due to inadequate fixation or disease progression, which allowed the device to move in relation to its intended and original position in the aorta.Stent migration most likely resulted in stent collapse or aortic branch coverage.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.
Event or Problem Description
N/a.

• Brand Name: STENTS I-CAST
• Common Device Name: 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: 12530603
• Report Number: 3011175548-2021-00997
• Device Sequence Number: 1140163
• Product Code: JCT
• UDI-Device Identifier: 00650862854459
• UDI-Public: 00650862854459
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2022

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: 03/20/2021
• Device Model Number: 85445
• Device Catalogue Number: 85445
• Device Lot Number: 429260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 02/28/2022; 10/18/2022
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 03/08/2022; 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC UNCOVERED STENT 8 MM X 40 MM.; BOSTON SCIENTIFIC UNCOVERED STENT 8MM X 40MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 96 KG