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

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problems Thrombosis (2100); Injury (2348)

Event Date 04/02/2020

Event Type  Injury  

Manufacturer Narrative

Journal article: journal of cardiology cases.Title:a case of very late stent thrombosis on the protruded struts at the left main coronary bifurcation author(s): yoshinobu murasatoa, kodai shibao, kyohei meno, katsuhiko takenaka ref: https://doi.Org/10.1016/j.Jccase.2020.04.007.Date of event: date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

An article titled 'a case of very late stent thrombosis on the protruded struts at the left main coronary bifurcation' was submitted.Patient underwent a zotarolimus-eluting stent implantation in the proximal left anterior descending artery for acute myocardial infarction 3 years previously and had been treated with dual antiplatelet therapy.The patient experienced chest pain and suddenly collapsed due to acute coronary syndrome caused by a huge thrombus in the left main coronary bifurcation.After insertion of the intra-aortic balloon pump, kissing balloon inflation improved coronary flow and hemodynamics.Two weeks later, a 3-dimensional optical frequency domain imaging (3-d ofdi) revealed uncovered protruded struts on the ostium of the left circumflex artery (lcx).The protruded struts were removed by using a double lumen catheter, for which the second wire was advanced to more distal cell along with the first wire located in the same lcx branch.3- d ofdi clearly demonstrated that uncovered protruded struts at the lcx ostium were the cause of vlst and navigated optimal wiring with a double lumen catheter.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10830626
• MDR Text Key: 215973233
• Report Number: 9612164-2020-04401
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160043
• 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: 11/12/2020

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: 10/24/2020
• Initial Date FDA Received: 11/12/2020
• 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: 56 YR