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

Model Number	85453
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Aneurysm (1708); Obstruction/Occlusion (2422); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
Patient had an icast stent implanted on (b)(6) 2016.On (b)(6) 2016, post-procedure imaging was performed.The site noted and the core lab evaluation revealed that the left renal artery within the stent was not patent.There was no endoleak, separation of components, or device integrity issues.A type ii endoleak was noted.On (b)(6) 2016, the patient underwent a secondary intervention to treat the occlusion of the left renal artery stent.Treatment included percutaneous placement of a cook 7 mm x 20 mm formula 418 stent.The site indicated the secondary intervention was successful.
Additional Manufacturer Narrative
Additional information section h.6.
Event or Problem Description
N/a.
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).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.Based on the details of the complaint and the images provided from the case, it would appear that there is a possibility that the occlusion was located at the distal end of the stent based on the pre operative images provided.The contrast is seen entering the kidney branches and back flow of the contrast around the distal end of the stent.This suggests that the stent is not dilated sufficiently against the vessel wall or there was possible movement of the p graft contributing possibly to the endoleak.The ring of the graft fenestration appears to be pushed inward as the stent extends approximately 50% of the width of the aorta.There was also a significant waist as the stent passes through the fenestration ring of the endograft.Based on the review of the device history records, the images provided and the details provided of the complaint, the complaint can be confirmed however there is no evidence to conclude that the stent was the cause of the adverse event.In this regard the complaint cannot be confirmed to be the fault of the icast covered stent and the root cause likely attributed to the operational context.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, excessive manipulation and use of force during device placement, restenosis of stented lesion and systemic embolization.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: 12352020
• Report Number: 3011175548-2021-00870
• Device Sequence Number: 11975256
• Product Code: JCT
• UDI-Device Identifier: 00650862854534
• UDI-Public: 00650862854534
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2022

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: 05/11/2019
• Device Model Number: 85453
• Device Catalogue Number: 85453
• Device Lot Number: 238332
• 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: 08/11/2021
• Supplement Date Received by Manufacturer: 10/27/2022; 10/27/2022
• Initial Report FDA Received Date: 08/22/2021
• Supplement Report FDA Received Date: 10/26/2022; 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2016
• 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: COOK 7 MM X 20 MM FORMULA 418 STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 210 KG