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

Catalog Number RONYX27526X

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

Patient Problem Stroke/CVA (1770)

Event Date 11/05/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the index procedure, two resolute onyx drug eluting stents were implanted in the lad. 9 days post index procedure, the patient suffered cerebral infarction. The patient died 9 days later. The patients death was classified as non cardiac death. The investigator and safety assessed the event as not related to the index device or anti-platelet medication.

Manufacturer Narrative

Event date changed to the (b)(6) 2018. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: cec adjudicated the death event as vascular death and commented that the patient died from stroke. 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: 8188656
• MDR Text Key: 131126669
• Report Number: 9612164-2018-03750
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/16/2019
• Device Catalogue Number: RONYX27526X
• Device Lot Number: 0008993358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/02/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 05/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/21/2018 Patient Sequence Number: 1