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 Problem Occlusion (1984)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Article received: mcelligott, h.E.(2020).Hybrid covered endovascular reconstruction of the aortic bifurcation (cerab) procedure is preferable to aortobifemoral bypass for limb-threatening aoartoiliac occlusive disease during the covid-19 crisis.Journal of vascular surgery cases and innovative techniques, 703-706.Purpose: this case report describes the management of a patient with complex aortoiliac occlusive disease by a hybrid endovascular approach in light of these constraints, with a successful outcome.Method: a case study per the article adverse events included occlusion.

Event Description

N/a.

Manufacturer Narrative

Article reviewed: mcelligott, et al.(2020).Hybrid covered endovascular reconstruction of the aortic bifurcation (cerab) procedure is preferable to aortobifemoral bypass for limb-threatening aortoiliac occlusive disease during the covid 19 crisis.J cardiovasc surg, cases and innovative techniques; 6:703-706.The subject article is a case report of 57-year-old man with acute-on-chronic transatlantic inter-society consensus ii (tasc ii) d aortoiliac occlusive disease managed by covered endovascular reconstruction of the aortic bifurcation as an alternative to open surgery in the era of covid-19.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 right internal iliac was unintentionally occluded and right superficial femoral artery embolectomy was necessary because of acute embolus, however the patient did not require a critical care bed postoperatively, his rest pain resolved and he was discharged home.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 this patient are potentially multifactorial and an atrium advanta v12tm balloon expandable covered stent was not the only attributing factor.The factors likely include but are not limited to, the patient¿s (tasc ii) d aortoiliac occlusive disease, preexisting occlusion of left internal iliac artery and the large-volume right common iliac artery aneurysm thrombus.The authors do not attribute development of complications to any particular stent type.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: 11382573
• MDR Text Key: 233725603
• Report Number: 3011175548-2021-00219
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• 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: 11/16/2022
• 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
• Patient Age: 57 YR
• Patient Sex: Male