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

Catalog Number RONYX40018X

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

Patient Problem Rupture (2208)

Event Date 10/10/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Anterior descending vessels rupture was reported.It was reported that after the stents were placed at the site of the disease, posterior dilation of the balloon for posterior vasodilation, contrast extravasation in the middle and distal segment of the stent was observed.The event was treated with percutaneous transluminal coronary intervention.The investigator and sponsor assessed the event as possibly related to the index device, but unlikely to be related to the antiplatelet medication.The patient is not recovered.

Manufacturer Narrative

Patient is a previous smoker with a medical history of hypertension.The index procedure was prompted by unstable angina and positive functional study.During the index procedure 2 resolute onyx des were implanted in the lad.Patient is recovered.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: 8054972
• MDR Text Key: 126657353
• Report Number: 9612164-2018-03129
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 01/17/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2019
• Device Catalogue Number: RONYX40018X
• Device Lot Number: 0008993359
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2018
• Initial Date FDA Received: 11/09/2018
• Supplement Dates Manufacturer Received: 12/26/2018
• Supplement Dates FDA Received: 01/17/2019
• Date Device Manufactured: 12/08/2017
• 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: 65 YR
• Patient Weight: 64