MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ADVANTA V12 LD COVERED STENT; STENT, ILIAC

Device Problem Collapse (1099)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

On completion of the investigation a follow-up report will be submitted.

Event Description

Received an article: reijnen, m.(2020).Update on covered endovascular recontruction of the aortic bifurcation.Vascular, 225-232.Purpose: to summarize all available evidence on this technique.Method: a systematic literature review was conducted on the results obtained using the cerab technique.Conclusion: cerab has proven to be the most optimal endovascular treatment option for aorto-iliac occlusive disease with regard to geometry and flow and is related to promising clinical outcomes.Per the article product problems included stent collapse.

Manufacturer Narrative

Article reviewed: reijnen et al.2020.Update on covered endovascular reconstruction of the aortic bifurcation.Vascular; 28(3):225-232.The subject article is a retrospective systematic review of 15 scientific publications, which include 152 unique patients who underwent covered endovascular reconstruction of the aortic bifurcation (cerab) over the last 15 years.In the current review, all available evidence on this technique was summarized.This complaint is based on information found within a article/literature review.There was no product that was available for evaluation, therefore a device evaluation could not be conducted and the complaint cannot be confirmed.The author of the article did not report any major adverse patient effects as result of this event.A device history record (dhr) review was unable to be performed as the device product part number and lot number was not provided within the article.Attempts to obtain the device lot information was conducted but unsuccessful.The hazardous situation/harm is addressed in the risk file and is operating within its risk profile.There was no evidence within the article that the device was the cause of the reported event.The complaint history review did not identify an adverse trend, therefore no escalation to capa process is required.Conclusion: the instructions for use clearly states that potential adverse effects of advanta v12 balloon-expandable stent include, but may be not limited to: inadequate implantation or intimal trauma, restenosis of stented lesion, stent misplacement, migration or deformation, systemic embolization or thromboembolic episodes.Considering the design of the study that consist of retrospective series of small group of experienced hospitals, the overall patency that is approaching three-year clinical outcome described for open surgery, clear trend that results are better in more complex group pf patients and the fact that there are design differences between the various balloon-expandable covered stents, one can infer that the getinge¿s advanta v12 balloon expandable covered stent performed as expected.H3 other text : product not returned.

Event Description

N/a.

• Brand Name: ADVANTA V12 LD COVERED STENT
• Type of Device: STENT, ILIAC
• 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: 11515946
• MDR Text Key: 242678230
• Report Number: 3011175548-2021-00333
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 12/09/2022
• Supplement Dates FDA Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention