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

Model Number	85453
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	09/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
Event: on (b)(6) 2016, the post procedure computed tomography (ct) scan was completed.The site analysis of the ct noted an occlusion of the left renal artery within the stent.The core lab analysis of the ct noted, ¿left renal stent graft occluded.The site noted that the ¿nosecone of unibody crushed icast stent.¿ on (b)(6) 2016, the patient underwent an unsuccessful secondary intervention to treat the occlusion of the left renal artery stent.The site stated, ¿a variety of catheters and guidewires were used to access the occluded left fenestration without success due to an anteroposterior crush and occlusion of the proximal end of the previously placed left renal stent.¿ the left renal stent remains occluded through the 5-year ((b)(6) 2021) ct scan.However, beginning with the 3-year ((b)(6) 2019) ct scan, core lab noted that the left renal stent is compressed.
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).Based on the provided details it would appear the migration of the p branch graft was the cause of the noted events.There were no images provided of the event.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 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, 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 and preprocedural miscalculation of the sizing and positioning of fenestration.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: 12566633
• Report Number: 3011175548-2021-01016
• Device Sequence Number: 3990531
• Product Code: JCT
• UDI-Device Identifier: 00650862854534
• UDI-Public: 00650862854534
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 05/07/2019
• Device Model Number: 85453
• Device Catalogue Number: 85453
• Device Lot Number: 238051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 10/03/2021
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADM 090020130 9X20 CM BALLOON
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 86 KG