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

Model Number	85445
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	11/10/2020
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
Report received stated that on (b)(6) 2020, the 12-month computed tomography (ct) scan was performed.The site noted that the ct scan revealed that the sma (within stent) was occluded.A type ii endoleak was noted.Core lab analysis of the ct scan revealed patent devices with 50% stenosis of the sma (within stent).There was no evidence of separation of components, kink, barb separation, stent fracture, or device compression.On (b)(6) 2020, a secondary intervention was performed.A viabahn vbx 8 mm x 29 mm covered stent was placed in the sma.The secondary intervention was successful.
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)(6).A review of the details and the images provided pre and post intervention shown are difficult to follow as the all the images provided have a stent in place that has radiopaque marker bands at the distal end of the stent.The icast covered stent is not manufactured with ro markers bands on the stent.It is likely the images provided include the use of the gore viaban product that was used during the secondary intervention.As part of the original interaction questions were asked surrounding the circumstances related to the case.One question that was asked is the following: "how is it determined that the endograft had not moved during the 12month follow up?¿ response: ¿the sites and core lab look for migration >/= 10 mm on the ct scans¿.This information is important as the stent used was a 7mm stent.If the p branch graft used in the case was to migrate 3.5mm that could potentially relate to a 50% reduction in the internal diameter of the icast covered stent.As none of the images show just the icast covered stent prior to intervention this complaint cannot be confirmed and there are many unknown circumstances surrounding this type of procedure.Based on the provided details and images provided it would appear that the most likely cause of the 50% stenosis is the possible migration of the p branch graft.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 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.
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: 12566639
• Report Number: 3011175548-2021-01017
• Device Sequence Number: 14307790
• Product Code: JCT
• UDI-Device Identifier: 00650862854459
• UDI-Public: 00650862854459
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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: 02/16/2022
• Device Model Number: 85445
• Device Catalogue Number: 85445
• Device Lot Number: 443178
• 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: 09/21/2021
• 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: 02/25/2019
• 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: 7X12CM BALLOON, 8MMX20MM STENT; 7X12CM BALLOON, 8MMX20MM STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 78 KG