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

Catalog Number RONYX25022X

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

Patient Problems Death (1802); Unspecified Infection (1930); Myocardial Infarction (1969)

Event Date 12/06/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

During the index procedure one resolute onyx des was used to treat the cx.Approximately 6 months post procedure patient suffered critical limb ischemia.The patient was scheduled to undergo pci but died.The investigator and sponsor assessed the event as not related to the index device or to the anti-platelet medication.Cec adjudicated the death as vascular, non-q wave mi of the target vessel, 3rd udmi peri-pci.Cec commented peripheral vascular disease.

• 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: 8987589
• MDR Text Key: 157284821
• Report Number: 9612164-2019-03850
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: LO
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2020
• Device Catalogue Number: RONYX25022X
• Device Lot Number: 0008963273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2019
• Date Device Manufactured: 01/23/2018
• 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
• Patient Age: 76 YR
• Patient Weight: 80