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

Model Number RONYX30026UX

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

Patient Problems Death (1802); Septic Shock (2068)

Event Date 06/08/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

One resolute onyx device was implanted in the lad during the index procedure.It was reported that approximately 22 months post index procedure that the patient died of an unknown cause.Safety assessed the event as not related to the procedure or device.

Manufacturer Narrative

Additional information: it was reported that patient suffered septic shock during scheduled procedure to change pacemaker and died.Investigator assessed that the event was not related to index device or antiplatelet medication.Correction: event occurred approximately 10 months post index procedure, not 22 as previously reported.Sponsor assessed the event is not related to antiplatelet medication.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: cec adjudicated the death event as cardiac death.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: 9310457
• MDR Text Key: 166001218
• Report Number: 9612164-2019-04722
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557017
• UDI-Public: 00643169557017
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2020

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: 03/03/2019
• Device Model Number: RONYX30026UX
• Device Catalogue Number: RONYX30026UX
• Device Lot Number: 0008521262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 01/24/2020; 02/06/2020
• Supplement Dates FDA Received: 02/05/2020; 02/13/2020
• Date Device Manufactured: 03/03/2017
• 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; Hospitalization
• Patient Age: 63 YR
• Patient Weight: 66