MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE ONYX RX; STENT, CORONARY, DRUG-ELUTING

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event is date article available on line.Journal article title: intracoronary nitroglycerin injection through a microcatheter for coronary no-reflow following percutaneous coronary intervention international journal of cardiology 214 (2016) 400¿402 0167-5273/© 2016 elsevier ireland ltd.All rights reserved.Contents lists available at sciencedirect international journal of cardiology journal homepage: www.Elsevier.Com/locate/ijcard journal article internet address: http://dx.Doi.Org/10.1016/j.Ijcard.2016.

Event Description

Patient visited the emergency department for ongoing chest pain for 2 hours.Cag was performed and showed total occlusion of the mid-left anterior descending artery.After balloon angioplasty with a conventional compliant balloon, a resolute onyx drug-eluting stent was implanted.However, post-stenting angiography revealed the no-reflow phenomenon.A microcatheter was positioned at the mid lad and abciximab and nitroglycerin were injected through the guiding catheter but failed to improve the timi flow.Then, the physician introduced and positioned a microcatheter (non-mdt) into the middle part of the rca and injected about 8 ml nitroglycerin through the microcatheter after removing the coronary guidewire.The follow-up angiogram revealed improved coronary flow at the proximal to distal coronary artery.Physician carried out several additional nitroglycerin injections through the microcatheter.The final angiogram showed much improved coronary flow without any complications.The patient became asymptomatic and was discharged without complications.Please note that this device resolute onyx is not marketed in the united states; however, it is similar to the united states marketed device resolute integrity.This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• 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: 5924531
• MDR Text Key: 53808377
• Report Number: 9612164-2016-00934
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P110013
• 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,Followup
• Report Date: 08/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2016
• Initial Date FDA Received: 09/02/2016
• Supplement Dates Manufacturer Received: 08/07/2016
• Supplement Dates FDA Received: 09/25/2017
• 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: 52 YR