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

Device Problem Leak/Splash (1354)

Patient Problems Inflammation (1932); Ischemia (1942); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

We are unable to fully investigate this report as no product number, lot number or sample was provided.It is not known what relationship the advanta v12 has to the reported adverse events.The study concluded fb-evar was feasible for post-dissection thoracoabdominal aneurysm.Despite the associated peri-operative risk and high probability of planned or unplanned reintervention, the procedure led to favorable aortic remodeling with false lumen thrombosis and aneurysm regression.Based on the information available atrium has determined that the events described are not related to a product failure.Not available for return.

Event Description

Received an article titled fenestrated or branched endovascular aortic repair for post-dissection thoracoabdominal aortic aneurysm.Purpose: fenestrated or branched endovascular aortic repair (fb-evar) usually represents the last stage in endovascular treatment of post-dissection aneurysm after thoracic endograft coverage of entry tear and false lumen embolization.Method: between january 2014 and december 2017, consecutive patients who underwent fb-evar for treatment of post-dissection thoracoabdominal aneurysm (taaa) in one center were included and retrospectively reviewed.Per the article adverse events included: type iii endoleak, spinal cord ischemia, systemic inflammatory response syndrome, respiratory failure, acute kidney injury, bleeding complications and wound complications.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, RENAL
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 8841976
• MDR Text Key: 152675056
• Report Number: 3011175548-2019-00817
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• 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: 07/22/2019
• 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
• Treatment: ZENITH FENESTRATED ENDOGRAFT SYSTEM - COOK
• Patient Outcome(s): Required Intervention