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

Model Number RONYX30015UX

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

Patient Problem Thrombus (2101)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

One resolute onyx rx coronary, drug eluting stent was used to treat a none tortuosity, severely calcified lesion exhibiting 80% stenosis in the proximal obtuse marginal (om).There was no issue removing the device from the hoop.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was pre dilated.The device did not pass through a previously deployed stent.It was reported that greater than 24 hours and less than 30 days post implantation the patient suffered stent thrombus.The patient is alive with no further injury.

Manufacturer Narrative

Additional information: there were no issues noted during stent deployment and the stent was fully deployed.The thrombus was treated using a cutting balloon and non-compliant balloon inside the stent.The patient was on dapt when this thrombotic event occurred.It was stated that it is believed that it was under-expansion of the stent that caused the event and that it could have happened to any stent due to the calcification.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 10471262
• MDR Text Key: 204924424
• Report Number: 9612164-2020-03233
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556980
• UDI-Public: 00643169556980
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2022
• Device Model Number: RONYX30015UX
• Device Lot Number: 0010185639
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 61 YR