MAUDE Adverse Event Report: ATRIUM MEDICAL CORPROATION ADVANTA V12 COVERED STENT; PTFE COVERED STENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

A complete investigation was not performed as no product code, lot number or sample was provided.Questions were sent to the author of the article.No response was received.The study concluded similar results when using fenestrated or chimney endografts.The author states that c-evar may be an appealing and efficient alternative, not only in emergent settings but also in elective cases where f-evar is predicted to be technically difficult or is contraindicated.Associated file: 3011175548-2017-00060.

Event Description

Received an article titled: comparison of fenestrated endovascular aneurysm repair and chimney graft techniques for pararenal aortic aneurysm published in the journal of vascular surgery.The purpose of this article was to compare the results of fentestrated endovascular aneurysm repair (f-evar) and chimney endovascular aneurysm repair (ch-evar) within a single institution.Consecutive patients (80 f-evar and 38 c-evar) at one institution who met the criteria for either f-evar or c-evar.Per the article, procedural complications included one death related to a graft infection at 45 months post procedure.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPROATION; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPROATION; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: lynda mclaughlin rn, bsn,ccrn-k ; 40 continental blvd; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 6814912
• MDR Text Key: 83455824
• Report Number: 3011175548-2017-00061
• 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,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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