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

Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395)

Patient Problem Hemorrhage/Bleeding (1888)

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 study, complex vascular interventions can be optimized using con beam ct fusion, minimizing nephrotoxicity with a trend toward lower radiation exposure and length of intervention.

Event Description

Received an article titled "image fusion for hybrid repair of dislocated superior mesenteric branch of a branched endovascular aortic graft" published in the journal of vascular surgery.The article introduced a case in which fusion technology was used for the placement of two thoracic and one branched abdominal aortic endograft and to treat late dislocation of its side branch using a hybrid technique.Per the article adverse events included endoleak and migration.

• 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: 8130262
• MDR Text Key: 129244301
• Report Number: 3011175548-2018-01439
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Device Age: YR
• Date Manufacturer Received: 11/16/2018
• 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
• Patient Age: 60 YR