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

Catalog Number RONYX25026X

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 06/19/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

During the index procedure, one resolute onyx des was implanted in the circumflex.It was reported that a family phoned and informed that the patient died - unknown classification.Investigator assessed that the event is not related to index device or antiplatelets medication.

Manufacturer Narrative

Sponsor assessed the event as not related to the anti-platelet medication and possibly related to index device.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

It was reported that he patient suffered 'sepsis related to a possibly respiratory organ' 12 days prior to the patients death.The patient was treated with medication.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The ae term was updated to 'pneumonia due to broncho aspiration.' if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Cec adjudicated the event as death non-cardiovascular.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: 7669179
• MDR Text Key: 113390218
• Report Number: 9612164-2018-01663
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup,Followup,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2019
• Device Catalogue Number: RONYX25026X
• Device Lot Number: 0008892267
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2018
• Date Device Manufactured: 11/23/2017
• 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): Death
• Patient Age: 70 YR
• Patient Weight: 82