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

Model Number	RONYX22518UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: a highly calcified lesion.The devices were prepped per ifu with no issues noted.It was indicated that excessive force was used when withdrawing both onyx devices.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.
Event or Problem Description
During a procedure an attempt was made to use one resolute onyx rx (4.00 x 26mm) and one resolute onyx rx (2.25 x 18mm) drug eluting stents to treat a lesion.The devices were inspected with no issues noted.The lesions were not pre-dilated.Negative prep was not performed.The devices did not pass through a previously deployed stent.Resistance was encountered when advancing the resolute onyx rx (4.00 x 26mm) device.Resistance was not encountered when advancing the resolute onyx rx (2.25 x 18mm) device.Excessive force was not used during delivery of either device.It was reported that both stents dislodged during removal following failed deliveries.It was reported that after the resolute onyx rx (4.00 x 26mm) failed to cross the lesion it was pulled back into the y adapter.The stent then got "hung up" on the y adapter and came off the delivery catheter.It was reported that the resolute onyx rx (2.25 x 18mm) dislodged in the y adapter.Both devices were retrieved successfully.The dislodged stents were removed by the physicians hand.No patient injury was reported.

• 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: 9710352
• Report Number: 9612164-2020-00714
• Device Sequence Number: 14270363
• Product Code: NIQ
• UDI-Device Identifier: 00643169556720
• UDI-Public: 00643169556720
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 04/08/2020

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: 04/07/2021
• Device Model Number: RONYX22518UX
• Device Catalogue Number: RONYX22518UX
• Device Lot Number: 0009684415
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1