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

Device Problem Insufficient Information (3190)

Patient Problems Renal Failure (2041); Rupture (2208); Thromboembolism (2654); Restenosis (4576)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Article: çakmak eö, s.M.(2021).Primary patency and amputation free survival after endovascular management of infrarenal aorta total occlusions.Anatol j cardiol, 258-65.Purpose: endovascular therapy (evt) has increasingly been used even after the development of new techniques and technologies.Evt has displayed durable early and mid-term outcomes for infrarenal aorta occlusions (iao).Nonetheless, little is known regarding their long-term outcomes and predictors of restenosis.Method: a total of 55 consecutive patients (age, 58.8±6.97 years; 67.2% male; 42% critical limb ischemia) from a single-center database, under-going evt for iao disease between january 2011 and march 2019 were retrospectively analyzed.Balloon-expandable stents were favorably used in cal-cified lesions and/or when reconstruction is needed.Conclusion: in this study, five-year outcomes of primary patency and amputation free survival for evt of infrarenal aorta total occlusive lesions were favorable.None of the demographic, lesion, and device factors were independently associated with loss of primary patency.Per the article adverse events included: embolic events : renal failure, iliac rupture, thrombosis, restenosis.

Manufacturer Narrative

Article reviewed: cakmak, et al.(2021).Primary patency and amputation free survival after endovascular management of infrarenal aorta total occlusions.Anatol j cardiol; turkey.25: 258-65.The subject article is a retrospective cohort study of 55 consecutive patients (age, 58.8±6.97 years; 67.2% male; 42% critical limb ischemia) from a single-center database, undergoing endovascular therapy (evt) for infrarenal aorta occlusions (iao) disease between january 2011 and march 2019.The outcome measures were primary patency rate and amputation free survival calculated by the kaplan¿meier method.Independent predictors of restenosis were assessed by cox propor-tional hazard regression model.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: although the study was a single-centered, retrospective, observational research using a small number of ethnic patient population and five-year outcomes of primary patency and amputation free survival for evt of infrarenal aorta total occlusive lesions were favorable, however seven restenosis were diagnosed during follow up, and six of them underwent repeat angioplasty.The authors do not attribute those vascular events to any particular stent.After review of the details provided, one can infer that getinge¿s advanta v12 stents performed as expected and the major risk factors for developing stent occlusions were underlying comorbidities, anatomic features of the patients and advanced aorto-iliac artery disease.

Event Description

N/a.

• Brand Name: ADVANTA V12 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: 11998094
• MDR Text Key: 256153444
• Report Number: 3011175548-2021-00663
• 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,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer 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