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

Catalog Number RONYX35018UX

Device Problems Mechanical Problem (1384); Material Deformation (2976)

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

Event Date 07/09/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A resolute onyx drug eluting stent was intended to be used during a procedure.The intended lesion was located in the cx artery.There was abnormalities reported in relation to anatomy- an anomalous lcx.There was no damage noted to packaging.There were no issues removing the device from the hoop.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.It is reported that stent deformation occurred in-vivo during positioning/advancement.The stent could not cross the lesion.When the stent was removed from the patient, it was noted that a stent strut in the middle of the stent was lifted up.The procedure was completed using another 3.5x18 onyx.No patient injury is reported.

Manufacturer Narrative

Additional information received reported that the lesion was in the anomalous left circumflex (originating off of the rca), with moderate tortuosity.The lesion exhibited 90%.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.

Manufacturer Narrative

Product analysis summary: there was a kink on the catheter 12.8cm distal to the strain relief.The stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 7th and 8th distal stent wraps with struts raised.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.

• 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: 7697466
• MDR Text Key: 114679622
• Report Number: 9612164-2018-01780
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557086
• UDI-Public: 00643169557086
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• 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,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2020
• Device Catalogue Number: RONYX35018UX
• Device Lot Number: 0009006916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 07/18/2018
• Supplement Dates Manufacturer Received: 07/30/2018; 08/08/2018; 09/07/2018
• Supplement Dates FDA Received: 08/28/2018; 10/03/2018; 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2018
• 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 Age: 73 YR
• Patient Weight: 122