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

Catalog Number RONYX45012X

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A resolute onyx rx drug eluting stent was intended to be used during a procedure.The target lesion was at the proximal rca with moderate calcification and severe tortuosity.No damage noted to device packaging and no issues removing the device from the hoop/tray.The device was inspected with no issues noted.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered while advancing the device to the target lesion.Excessive force was not used during attempted delivery.Stent dislodgement was reported to have occurred during removal of the device following failed delivery.When stent was prepositioned at the proximal rca, with moderate exertion due to tortuosity of the vessel, it was realized that the stent was long for the lesion.The stent system was removed but it was suddenly realized that the stent was no longer there.Upon checking the location of where stent that was supposed to be dislodged, stent was nowhere to be found.No injury to the patient reported.The procedure was completed with a shorted drug eluting stent.

Manufacturer Narrative

Product analysis summary: stent was positioned between the markerbands but not meeting specifications due to deformation of the proximal wraps.Deformation was evident to the 12th distal stent wraps with struts raised.No deformation was evident to the distal tip.The inner lumen patency could not be verified with a 0.015 inch mandrel most likely due to hardened blood in the guidewire lumen.No other damage evident to the remainder of the device.The device returned with stent in position on balloon.It was reported that the correct device returned, and stent dislodgement was reported in error.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: 8273361
• MDR Text Key: 133946597
• Report Number: 9612164-2019-00299
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2020
• Device Catalogue Number: RONYX45012X
• Device Lot Number: 0009184183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2018
• 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
• Patient Age: 66 YR