MAUDE Adverse Event Report: MEDTRONIC IRELAND ASSURANT COBALT; STENT, ILIAC

Lot Number UNKNOWN

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

Patient Problems Intimal Dissection (1333); Stroke/CVA (1770); Embolism (1829); Occlusion (1984); Stenosis (2263)

Event Date 01/29/2019

Event Type  Injury  

Manufacturer Narrative

Journal article: periprocedural and long-term outcomes of stent implantation for de novo subclavian artery disease doi: 10.1177/1538574418824444.Average age majority gender date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

The purpose of the current study was to investigate the periprocedural and long-term outcomes of stent implantation for de novo subclavian artery (sca) disease.Patients with de novo sca lesions who underwent evt procedures were included in the analyses of periprocedural outcomes.Assurant cobalt stents, driver bare metal stents and resolute integrity drug eluting stents were among the stents implanted.Clinical outcomes reported included stenosis, restenosis, occlusion, re intervention of the target vessel, distal embolism, dissection, pseudoaneurysm at access sites, hematoma at access sites, death and stroke.

• Brand Name: ASSURANT COBALT
• 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: 8644223
• MDR Text Key: 146220999
• Report Number: 9612164-2019-01992
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2019
• 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: 71 YR