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

Catalog Number RONYX30012X

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

Patient Problems Death (1802); Unspecified Infection (1930)

Event Date 09/25/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

Two resolute onyx des was implanted in the rca during the index procedure.Approximately five days post index procedure, the patient suffered cardiac tamponade (most likely due to wire position during staged pci).Emergency pericardiocentesis was performed.The patient had hypotension due to rv infection, and experienced multi-organ failure.It was reported patient underwent a staged procedure.Patient died approximately 6 days post index procedure.Death was reported as sudden cardiac death.The investigator assessed the event as not related to the device or antiplatelet medication.Sponsor assessed the event as possibly related to the device and not related to anti-platelet medication.Safety assessed the cardiac tamponade event as possibly related to the index device and not related to anti-platelet medication.

Manufacturer Narrative

The date of death was updated to (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Date of death was updated.Cec adjudicated bleeding complication barc type 5b, tamponade lead to death.Cec adjudicated death as cardiac.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Death was reported to be a non-sudden cardiac death.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the lot number of the resolute onyx implanted is unknown.The previously reported device was not implanted during the procedure.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the second resolute onyx des was implanted in the rca during a staged procedure if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: cec adjudicated the bleeding event as barc type 5b and commented that tamponade leads to death.Cec adjudicated the death event as cardiac death.Investigator assessed that the event was not related to index device.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the lot number of the second implanted resolute onyx was provided.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: one of the resolute onyx stents implanted was implanted during a revascularization to treat myocardial infarction.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The lot number for the second resolute onyx was updated to unknown.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 8365664
• MDR Text Key: 136979399
• Report Number: 9612164-2019-00617
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2020
• Device Catalogue Number: RONYX30012X
• Device Lot Number: 0009157415
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 97