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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Ischemia (1942); Thrombus (2101); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Article received: falkensammer, j.E.(2020).Assessment of pull-out forces in tevar and anaconda fevar combination and early clinical results:.Annals of vascular surgery, 160-170.Purpose: to assess the stability of a fenestrated anaconda device implanted into a set of thoracic endografts from different manufacturers.Method: a study of 172 patients between april 2013 and december 2018.Conclusion: the combination of a thoracic tube graft and a fenestrated anaconda device is a viable option for the treatment of patients with extent i or iv taaas with no adequate landing zone above the celiac trunk.Per the article adverse events occurred including ischemia, dissection, thrombus, blood loss and migration.

Event Description

N/a.

Manufacturer Narrative

Article reviewed: falkensammer, et al.(2020).Assessment of pull-out forces in tevar and anaconda fevar combination and early clinical results: creation of a proximal landing zone for fevar in patients with extent i and extent iv taaas.Annals of vasc surg; 66:160-170.The subject article is an in vitro study of pull-out forces measured after docking a fenestrated anaconda graft within the distal end of different tevar devices.Anaconda devices were implanted in 28- or 30-mm thoracic tube grafts (oversizing of at least 2 mm: 13.3-21.4; minimum overlap of 15 mm).Continuously increasing longitudinal pull forces of up to 100 n were applied on an instron tensile tester.Initial break point and damage to the endografts were documented.Clinical results of patients treated with such an fevar/tevar combination at our institution are presented as a second part of this study.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: inadequate implantation or intimal trauma, restenosis of stented lesion, stent misplacement, migration or deformation, systemic embolization or thromboembolic episodes.Although considering the relatively low primary technical success rate (71.4%) and high early unplanned reintervention rate (28.6% at 30 days) one should remember the high complexity of this series of patients with thoracoabdominal aortic pathologies.Increased complexity and complication rates directly impact in vitro and in vivo results of the current study.Overall results support the feasibility of a tevar and anaconda fevar combination to treat patients with a paravisceral aneurysm with no suitable anatomy for a branched device.The getinge¿s advanta v12tm balloon expandable covered bridging stents performed as expected 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: 11388004
• MDR Text Key: 233964274
• Report Number: 3011175548-2021-00228
• 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: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• 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
• Was the Report Sent to FDA?: 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