MAUDE Adverse Event Report: MEDTRONIC IRELAND COMPLETE SE ILIAC; STENT, ILIAC

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

Patient Problems Neurological Deficit/Dysfunction (1982); Pseudoaneurysm (2605)

Event Date 11/25/2018

Event Type  Injury  

Manufacturer Narrative

Age: average age.Majority gender journal article title: management of type b aortic dissection with an isolated left vertebral artery copyright _ 2019 by the society for vascular surgery.Published by elsevier inc.Https://doi.Org/10.1016/j.Jvs.2018.11.052 1065.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported in the literature article, management of type b aortic dissection with an isolated left vertebral artery, that 9 patients, out of the 31 mentioned, received a chimney stent.All patients received aortic stent grafts; nine patients also received chimney stents, and 10 patients received aortic arch bypasses.One patient received a complete se stent and two received a maris stent.The technical success rate was 96.8%, with only one patient (3.2%) showing immediate type ia endoleak.One patient experienced transient neurologic deficit, and a puncture-related femoral artery pseudoaneurysm was observed in one patient; both recovered completely before their hospital discharge.There was no death in the early term.The median duration of follow-up was 33 months.Reintervention for a type ii endoleak by using coils to seal the origin of the left subclavian artery was performed in one case 72 months postoperatively.One death occurred 42 months after operation as a result of rectal cancer.Thirteen patients received a valiant thoracic aortic stent graft.No neurologic deficits, chimney stent occlusions, or bypass occlusions were observed during the follow-up period.

• Brand Name: COMPLETE SE ILIAC
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9259325
• MDR Text Key: 167118225
• Report Number: 9612164-2019-04557
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: 0703440252
• 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: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• 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: 10/10/2019
• 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: 55 YR