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

Device Problem Insufficient Information (3190)

Patient Problems Infarction, Cerebral (1771); Hematoma (1884); Renal Disease, End Stage (2039); Weakness (2145)

Event Type  Injury  

Manufacturer Narrative

A complete investigation was not able to be 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 that c-evar is feasible and efficient to treat jaa in patients unsuitable for fenestrated branched endografts (fbe).However, in this preliminary experience, complications of devices insertion and type i endoleaks were not rare.Associated files: 3011175548-2017-00062, 3011175548-2017-00063, 3011175548-2017-00064, 3011175548-2017-00065, 3011175548-2017-00066, 3011175548-2017-00068.

Event Description

Received an article titled: technical aspects, current indications, and results of chimney grafts for juxtarenal aortic aneurysms published in the journal of vascular surgery.The purpose of this article was to report preliminary experience with chimney grafts for juxtarenal aortic aneurysms (jaa) in an effort to review its indications in the era of fenestrated branched endografts.From 2000 to 2010, 57 patients with endovascular repair of aortic aneurysms were reviewed.Sixteen (16) patients with c-evar.Per the article, procedural complications included one patient with a retroperitoneal hematoma, right cva, right renal infarction resulting in left upper limb weakness and stage iii chronic renal insufficiency.

• 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: 6814958
• MDR Text Key: 83476219
• Report Number: 3011175548-2017-00067
• 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: 08/16/2017

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): Death
• Patient Age: 78 YR