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 Hemorrhage/Bleeding (1888); Obstruction/Occlusion (2422); Valvular Stenosis (2697)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Received an article: cucuruz, b.E.(2020).Midterm outcome of renal function after branched thoracoabdominal aortic aneurysm repair.Journal of vascular surgery, 1119-1127.Purpose: to investigate the incidence and impact of acute and chronic kidney dysfunction after branched endovascular aortic aneurysm repair (bevar) perioperatively and during follow-up.Method: patients with a thoracoabdominal aortic aneurysm were treated with bevar were evaluated.Conclusion: prevention of acute kidney injury using staged procedures, early interventions for renal side branch complications, and regular surveillance is recommended during and after bevar to improve outcomes.Per the article adverse events included thromboembolic events, stenosis, bleeding and occlusion.

Event Description

N/a.

Manufacturer Narrative

This complaint is based on information within an article and no specific device information has been provided.As there is insufficient details of an actual device malfunction or adverse event that occurred the complaint cannot be confirmed.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.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.Although postoperative acute kidney injury was observed in 36% of patients treated with branched endovascular aortic aneurysm repair for taaa, 10 patients with aki had postoperative dialysis and cumulative risk for dialysis postoperatively was 6.7%, however considering the study design, the fact that 4 patients recovered without dialysis, that staged procedures decrease the risk of aki after bevar and significantly increased levels of creatinine and that after 2 years of follow-up renal function was restored in more than 85% of patients, one can infer that the getinge¿s advanta v12¿ balloon expandable covered stents performed as expected.Authors do not attribute adverse events to any particular type of bridging stents.

• 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: 11458421
• MDR Text Key: 244176045
• Report Number: 3011175548-2021-00269
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• 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: 08/21/2022
• 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