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

Catalog Number RONYX22515UX

Device Problems Material Frayed (1262); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It is reported that an attempt was made to use resolute onyx drug eluting stent to treat a lesion in a patient.It was reported that the stent failed to cross the lesion and became frayed.The procedure was completed using a 2.5x15 mm resolute onyx stent.No patient complications reported for this event.

Manufacturer Narrative

Additional information: the lesion stenosis, tortuosity and calcification were moderate.The device was inspected before use.The lesion was pre-dilated.Some resistance was noted while advancing the device to the lesion.Evaluation summary: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 4th distal stent wraps with struts raised.No deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 7713310
• MDR Text Key: 114943691
• Report Number: 9612164-2018-01839
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556713
• UDI-Public: 00643169556713
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110013
• 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: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2020
• Device Catalogue Number: RONYX22515UX
• Device Lot Number: 0008949575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2018
• 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