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

Model Number	RONYX22515UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Hematoma (1884)
Date of Event	12/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During index procedure, a resolute onyx drug eluting stent was implanted in the rca.Approximately 11 months post procedure, patient suffered subdural hematoma which is associated with bleeding event.Ct scan showed new right subdural fluid collection and hematoma.Investigator and sponsor assessed event is not related to device but possibly related to anti platelet medications.
Additional Manufacturer Narrative
Additional information: cec adjudicated bleeding complication barc type 3c.Cec adjudicated stroke as a no event.Event term was updated to "acute ischemic right mca stroke." cec assessment comment was no stroke by mri and repeat ct.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Investigator assessed that the event was not related to antiplatelets medication.Correction: patient recovered from subdural hematoma.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: patient recovered.Correction: initial reporter and facility corrected.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
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9609687
• Report Number: 9612164-2020-00345
• Device Sequence Number: 13590113
• Product Code: NIQ
• UDI-Device Identifier: 00643169556713
• UDI-Public: 00643169556713
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/24/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2020
• Device Model Number: RONYX22515UX
• Device Catalogue Number: RONYX22515UX
• Device Lot Number: 0009030146
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 01/30/2020; 02/11/2020; 02/09/2021
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 02/07/2020; 02/24/2020; 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 81 YR
• Patient Weight: 70