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

Catalog Number	RONYX40022UX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the physician intended to use resolute onyx drug eluting stent to treat a lesion in the tibioperoneal trunk.There were no abnormalities in relation to anatomy.There was no damage noted to packaging and no issues noted when removing the device from hoop/tray.The device was inspected with no issues identified.There was moderate tortuosity in the iliacs, however the sheath was advanced into the sfa and a guider placed throughout the sfa to prevent the stent from dragging in native tissue.The catheter shaft would not advance to the lesion, so it never crossed the lesion.The shaft bent during advancement which prevented further advancement; with continuous small movement advancements the shaft continued to bend preventing further advancement.It was reported that the resolute onyx catheter shaft cracked during removal of the device from the patient.The portion of the catheter shaft which cracked was inside the patient, distal to the haemostatic valve.The device cracked and was hanging by a thread and removed slowly by pulling back the delivery system.No intervention was used.The device did not break in two.The resolute onyx stent was intact on delivery system with no damage noted.It was not deployed and it was removed successfully.The stent was still attached to the balloon and no foreign material left in the patient.

• 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: 7066829
• Report Number: 9612164-2017-01686
• Device Sequence Number: 1091171
• Product Code: NIQ
• UDI-Device Identifier: 00643169557185
• UDI-Public: 00643169557185
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 11/29/2017

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: 05/30/2019
• Device Catalogue Number: RONYX40022UX
• Device Lot Number: 0008654332
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR