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

Catalog Number RONYX30008X

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

Patient Problems Death (1802); Myocardial Infarction (1969); Occlusion (1984); Thrombus (2101); Cardiogenic Shock (2262)

Event Date 01/01/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

During the index procedure two resolute onyx stents were implanted into the cx and one resolute onyx stent was implanted into the lcma.Approximately 5 months post index procedure, the patient suffered cardiogenic shock.Myocardial infarction of the target vessels- lcx and lm was also reported.The patient was treated with ptca and stenting with two resolute onyx implanted in the cx and lcma but passed away.The patient's death was classified as non sudden cardiac death.The investigator assessed the event as possibly related to the device and unlikely to be related to anti-platelet medication.Cec adjudicated non-q-wave mi (target vessel), 3 rd udmi spontaneous, prox cx, lcma.Cec adjudicated death, cardiac.Cec adjudicated tlr-pci as clinically driven of lcma and cx, reason for revascularization: clinical judgement.Cec adjudicated late stent thrombosis, arc definite- lcma & cx, due to occlusion of left main/lcx in setting of acute mi stent thrombosis.Cec also adjudicated thrombotic occlusion of the study stent did not occur subsequent to repeat pci of the target lesion and the stent thrombosis is not related to a non study stent or to non target lesion.

Manufacturer Narrative

The investigator assessed the mi as possibly related to the device and not related to anti-platelet medication.Mi was due to in-stent re stenosis.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: 8523153
• MDR Text Key: 142338687
• Report Number: 9612164-2019-01384
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 07/31/2019

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: 09/23/2020
• Device Catalogue Number: RONYX30008X
• Device Lot Number: 0009342071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 07/04/2019
• Supplement Dates FDA Received: 07/31/2019
• Date Device Manufactured: 09/24/2018
• 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; Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 79