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 Code	Obstruction/Occlusion (2422)
Date of Event	08/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
New event occurred on (b)(6) 2020, patient was diagnosed with a left renal artery within the stent occlusion.There was no treatment for this event.Related mdr: 3011175548-2021-00870.Previous event: patient had an icast stent implanted on (b)(6) 2016.On (b)(6) 2016, post-procedure imaging was performed.The site noted and the (b)(6) 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
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).As the stent was claimed to have no longer been patent there are multiple reasons for a stent to become occluded such as patents not following the prescribed medications in regards to blood thinners, malpositioning of the stent.If the stent is not long enough to cover the entire length of the lesion could create end cell restenosis.The first image provided described as pre-treatment shows that the introducer sheath extends the entire length of the stent with the shot of contrast showing a narrowing of the artery distal of the stent.This images does confirm the complaint in regards to the renal artery not being patent however it appears as if the stent itself is patent.In this regard the complaint cannot be confirmed to be 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, 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.
Additional Manufacturer Narrative
Additional information section: h.6 h3 other text : not available for return.

• 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: 12408175
• Report Number: 3011175548-2021-00908
• Device Sequence Number: 19879230
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2022

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: 08/20/2021
• Supplement Date Received by Manufacturer: 10/18/2022; 10/28/2022
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 10/26/2022; 10/28/2022
• 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; 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: 95 KG