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

Model Number	85408
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	04/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
As part of the zenith® p-branch® pivotal study being conducted by cook, inc., the following event was noted: event: on (b)(6) 2021 (1865 days post-procedure), the 5-year ct scan was performed.Site analysis noted devices had no evidence of separation of components, or device integrity issues.The sma (within the stent) was not patent.Core lab analysis of the ct scan noted devices had no evidence of separation of components or device integrity issues.Core lab noted that the sma stent graft was occluded proximally.Core lab also noted that the p-branch device migrated caudally.Core lab stated, ¿right renal stent graft appears to have significant in-stent stenosis, but unable to assess degree due to large slice thickness of ct scan.Also noted downward migration of p-branch component about 11mm forcing compression and proximal occlusion of sma stent graft.¿ on (b)(6) 2021 (1875 days post-procedure), a secondary intervention (si) was performed.Clinical signs and symptoms were diarrhea and abdominal cramping.A balloon angioplasty was performed, and a stent was placed.The si was successful.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information: a2, a3 and a4.
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)(6).Based on the details of the complaint the icast covered stent in the superficial mesenteric artery (sma) was not patent after the 5 year follow up exam.It was also noted that the icast covered stent in the right renal artery had significant in stent stenosis.Also noted downward migration of p branch component about 11mm forcing compression and proximal occlusion of sma stent graft.There were no images provided from the procedure and therefore cannot confirm the complaint.Based on the provided details it would appear the migration of the p branch graft was the cause of the noted events as migration of the graft would cause the proximal end of the stents to become compressed and deformed.The details mention that the p branch graft migrated 11mm.The icast covered stent placed was 9mm in diameter.This type of compression on the stents placed off the branch of the endograft that are fixed in placed in the artery would cause a high reduction of the patency of the stent if not kink the stents.Based on the provided information the cause of the complaint is most likely related to the migration of the p branch graft.Based on this investigation there is no indication the icast covered stent was the cause of the complaint.In this regard the complaint cannot be confirmed and the root cause likely attributed to the operational context.A review of the applicable device history records was unable to be performed due to the fact that the lot number of the device was not provided.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 events suffered by the 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.

• 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: 12037433
• Report Number: 3011175548-2021-00690
• Device Sequence Number: 3832292
• Product Code: JCT
• UDI-Device Identifier: 00650862854084
• UDI-Public: 00650862854084
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2022

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 Model Number: 85408
• Device Catalogue Number: 85408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 06/22/2021; 10/18/2022
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 06/22/2021; 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ZENITH P-BRANCH GRAFT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 102 KG