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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Wound Dehiscence (1154); Hematoma (1884); Ischemia (1942); Occlusion (1984); Renal Failure (2041); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number or sample was provided.Per the article, the analysis suggests no difference in terms of 30 day mortality, dialysis, or organ specific postoperative complications, with the exception of acute kidney injury.

Event Description

Received an article titled "a propensity-matched comparison of fenestrated endovascular aneurysm repair and open surgical repair of pararenal and paravisceral aortic aneurysms" published in the journal of vascular surgery.The article investigated the outcomes of a current series of patients treated with fenestrated and branched endovascular aneurysm repair (f-bevar) or open surgical repair (osr) for pararenal abdominal aortic aneurysms (pr-aaas).Per the article, adverse events included acute kidney injury (aki), renal failure, cardiac complications, pulmonary complications, thrombosis, retroperitoneal hematoma, wound dehiscence, intestinal ischemia and occlusions.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, RENAL
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 8128451
• MDR Text Key: 129171116
• Report Number: 3011175548-2018-01426
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• 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: 11/12/2018
• 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