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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolism (1829); Hematoma (1884); Rupture (2208)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Article received: mwipatayi, b.P.(2020).A systematic review of covered balloon-expandable stents for treating aortoiliac occlusive disease.Journal of vascular surgery, 1473-1486.E2.Purpose: to evaluate and compare studies reporting the outcomes of the use of covered balloon-expandable (cbe) stents for the treatment of aortoiliac occlusive disease.Method: a systematic literature search was conducted to identify studies that investigated the use of cbe stents for the treatment of aortoiliac occlusive disease and were published between 2000 and 2019.Conclusion: cbe stents are a viable treatment option for patients with complex aortoiliac lesions because of their high rates of technical success and favorable patency across all devices at 12 months.However, long-term data are only available for a single device, the icast/advanta v12.Per the article adverse events included: arterial rupture, hematoma and distal embolization.

Event Description

N/a.

Manufacturer Narrative

Article reviewed: mwipatayi, et al.(2020).A systematic review of covered balloon-expandable stents for treating aortoiliac occlusive disease.J vasc surg; 72:1473-86.The subject article is a systematic literature review of 15 published articles about 14 studies were included in the review.Of these, eight studies were prospective clinical trials and six studies were retrospective real-world studies.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: restenosis of stented lesion, short-term hemodynamic deterioration, systemic embolization or thromboembolic episodes, and vascular thrombosis.Although advanced lesion severity was associated with more procedural complications and diminished 12-month primary patency rates, however there were no differences between real-world and clinical trial outcomes with respect to 12-month patency and midterm follow-up.After review of the details provided, that clearly highlights the possible risks and complications known to occur following advanta v12tm balloon expandable covered stent implantation, one can infer the unfortunate injuries suffered by study patients are potentially multifactorial and a getinge¿s advanta v12tm balloon expandable covered stents were not the only attributing factor.The factors likely include but are not limited to, the patient¿s advanced occlusive disease, anatomically complex lesions, comorbidities and limitation of the current review with the lack of level 1 evidence comparing cbe stents to other treatment options for aiod.H3 other text : not available for return.

• 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: 11355968
• MDR Text Key: 232790538
• Report Number: 3011175548-2021-00195
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 02/20/2021
• Supplement Dates Manufacturer Received: 11/15/2022
• Supplement Dates FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention