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

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Article received: meijs, t.E.(2020).Epinephrine stress testing during cardiac catheterization in patients with aortic coarctation.American heart journal, 78-87.Purpose: we aimed to investigate whether epinephrine stress testing improves clinical decision making and outcome in coa.Method: we retrospectively evaluated coa patients (b)(6) kg with a peak systolic gradient (psg) =20 mm hg during cardiac catheterization who underwent epinephrine stress testing.Subsequent interventional management (stenting or balloon dilatation), complications, and medium-term clinical outcome were assessed.Conclusion: in coa patients with a low baseline psg but high epinephrine psg, percutaneous intervention is associated with a substantial reduction in systemic blood pressure and the use of antihypertensive medication.Per the article product problems included stent fracture and stent migration.

Manufacturer Narrative

Article reviewed: meijs, et al.(2020).Epinephrine stress testing during cardiac catheterization in patients with aortic coarctation.Am heart journal; 225:78-87.The subject article is retrospective observational study of 50 patients with aortic coarctation (coa) who were >50 kg with a peak systolic gradient (psg) =20 mm hg during cardiac catheterization who underwent epinephrine stress testing.Subsequent interventional management (stenting or balloon dilatation), complications, and medium-term clinical outcome were assessed.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: considering the retrospective observational design of the study with a relatively small sample size, high technical success rate, and the fact that percutaneous intervention is associated with a substantial reduction in systemic blood pressure and the use of antihypertensive medication, one can infer that getinge¿s advanta v12tm balloon expandable covered stents performed as expected.The authors do not attribute development of complications to any particular stent type.H3 other text: not available for return.

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: 11355966
• MDR Text Key: 234212740
• Report Number: 3011175548-2021-00194
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 02/20/2021
• 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
• 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