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

Catalog Number RONYX27526X

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Intimal Dissection (1333); Patient Problem/Medical Problem (2688); Vascular Dissection (3160)

Event Date 05/30/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the index procedure, three resolute onyx stents were implanted into the lad.A persistent stent edge dissection occurred in the proximal lad and was treated with poba during a staged procedure.The patient recovered.The investigator assessed the event as possibly related to the index device and not related to anti-platelet medication.

Manufacturer Narrative

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

Manufacturer Narrative

Adverse event date updated.The dissection in the proximal lad was caused by resolute onyx des.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Sponsor assessed the event as possibly related to the device and not related to the antiplatelet medication.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Cec assessed event was part of the index procedure.Event definition - no event.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: cec assessed the initial revascularisation as no event as it was part of the index procedure and assessed the stage procedure revascularisation as tlr pci of the lad clinically driven.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Event date changed to the (b)(6) 2018.The patient was not hospitalised.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: 7742004
• MDR Text Key: 115780254
• Report Number: 9612164-2018-01929
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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,Followup,Followup,Followup
• Report Date: 07/24/2019

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: 10/31/2019
• Device Catalogue Number: RONYX27526X
• Device Lot Number: 0008853573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2018
• Initial Date FDA Received: 08/02/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 10/12/2018; 03/29/2019; 05/09/2019; 05/28/2019; 07/22/2019
• Supplement Dates FDA Received: 10/02/2018; 10/19/2018; 04/16/2019; 05/24/2019; 06/19/2019; 07/24/2019
• Date Device Manufactured: 10/31/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 45