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

Catalog Number	RONYX20008UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Two resolute onyx drug eluting stents were intended to be used to treat a moderately calcified moderately tortuous lesion in the 1st om.Stenosis was 85%.No difficulties were noted when removing the protective sheath.The devices inspected before use with no issues noted.The lesion was pre-dilated.A non-medtronic stent was implanted first in the 1st om.After this stent was implanted it was thought that some of the burden had moved into the distal segment of the vessel.The inflation device remained on neutral pressure during delivery of the resolute onyx devices.Resistance was noted while advancing the devices to the lesion.Excessive force was used.There was a difficulty crossing the lesion.The two stents did not make it through the non-medtronic stent.The first resolute onyx stent slid up the shaft.The whole system was withdrawn and the stent was on the shaft of the stent catheter.The second resolute onyx stent was moving under the balloon when the system was withdrawn.The stent was removed without an issue on the stent cathe ter, but the stent actually came off the balloon as it was removed from the valve of the sheath.The sheath and guide were exchanged and the guide and a 3rd resolute onyx was placed successfully.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7710307
• Report Number: 9612164-2018-01823
• Device Sequence Number: 1120796
• Product Code: NIQ
• UDI-Device Identifier: 00643169556621
• UDI-Public: 00643169556621
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/02/2020
• Device Catalogue Number: RONYX20008UX
• Device Lot Number: 0008933671
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 11/08/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 10/03/2018; 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 108