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

Catalog Number RONYX20008UX

Device Problems Device Dislodged or Dislocated (2923); Physical Resistance/Sticking (4012)

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

Event Date 06/25/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event 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did not make it through the non-medtronic stent.The first resolute onyx stent slid up the shaft.The whole system was withdrawn and the stent was on the shaft of the stent catheter.The second resolute onyx stent was moving under the balloon when the system was withdrawn.The stent was removed without an issue on the stent cathe ter, but the stent actually came off the balloon as it was removed from the valve of the sheath.The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.

Manufacturer Narrative

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: 7710307
• MDR Text Key: 114942604
• Report Number: 9612164-2018-01823
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556621
• UDI-Public: 00643169556621
• 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
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2020
• Device Catalogue Number: RONYX20008UX
• Device Lot Number: 0008933671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2018
• Date Device Manufactured: 01/02/2018
• 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: 70 YR
• Patient Weight: 108