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

Model Number	85451
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Aneurysm (1708); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/31/2017
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 on 31jul2017, the post procedure computerized tomography (ct) scan was performed.Site analysis noted that the devices were patent with no evidence of separation of components, or device integrity issues.A type ii endoleak was noted.Core lab analysis of the ct scan noted patent devices with no evidence of separation of components or device integrity issues.A type iii endoleak was noted at the p-branch and the right renal stent.On (b)(6) 2018, the six-month follow-up ct scan and ultrasound were performed.Site analysis noted that the devices were patent with no evidence of migration, separation of components, or device integrity issues.A type ii endoleak was noted.Core lab analysis of the ct scan noted patent devices with no evidence of migration, separation of components, or device integrity issues.An unknown type endoleak was noted.Core lab noted, ¿unsure origin of endoleak.¿ core lab evaluation of the ultrasound noted patent vessels with an unknown type endoleak.Comments from core lab noted ¿endoleak on two cine loops: one suggests from the graft itself (type iv) (distal part of the fenestrated component) while another suggests from the ima (type ii).¿.
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 complaint is in regards to an endoleak.The details provided state that ¿ core lab evaluation of the ultrasound noted patent vessels with an unknown type endoleak.Comments from core lab noted ¿endoleak on two cine loops: one suggests from the graft itself (type iv) (distal part of the fenestrated component) while another suggests from the ima (type ii).¿it is not clear at what location based on this core lab evaluation where exactly the endoleak is coming from.If the seal between the icast stent and the p branch graft had separated or was not flared properly to make a good connection through the fenestration of the endograft, the inside of the p branch graft and the icast covered stent may explain the endoleak noticed however there is no indication that the endograft leak was caused by the icast covered stent alone.There were no images provided from the case and as such the complaint cannot be confirmed.There are multiple factors that could be attributed to the cause of the endoleak.The factors likely include but are not limited to, loss of apposition or disconnect between icast stent and the zenith® p branch® graft, surgical technique, such as inadequate flaring of the icast stent or pre procedural miscalculation of the sizing and positioning of fenestrations.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, loss of apposition or disconnect between icast stent and the zenith® p-branch® graft, surgical technique, such as inadequate flaring of the icast stent or preprocedural miscalculation of the sizing and positioning of fenestrations.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: 12565724
• Report Number: 3011175548-2021-01012
• Device Sequence Number: 16999232
• Product Code: JCT
• UDI-Device Identifier: 00650862854510
• UDI-Public: 00650862854510
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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: 03/01/2020
• Device Model Number: 85451
• Device Catalogue Number: 85451
• Device Lot Number: 248229
• 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: 10/01/2021
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2017
• 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: 10 X 2 CM BALLOON (MODEL # G23773)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 71 KG