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

Model Number	RONYX50012UX
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2018
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
It was reported that an attempt was made to use a resolute onyx drug eluting stent to treat a lesion in the mid lad with moderate tortuosity, severe calcification and exhibiting 100% stenosis (cto).There were no abnormalities reported in relation to anatomy.No damage was noted to packaging.There were no issues removing the device from the hoop/tray.No difficulties were noted when removing the protective sheath.The device was inspected with no issues noted.The lesion was predilated.The inflation device remained on neutral pressure during delivery of the device.The stent did not pass through a previously deployed stent.A guideliner was used when delivering the device.Resistance was encountered when advancing the device and no excessive force was used.It was reported that stent dislodgement occurred during delivery to/at lesion.The stent completely dislodged and crumpled.The physician felt the stentgot stuck and pulled out the whole system with the mangled stent within the guideliner.The dislodged stent was removed from the patient along with the guideliner.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: the stent was not present on the balloon but did return for analysis.The dislodged stent returned with deformation evident to the distal and mid-section stent wraps with the struts stretched and bunched.Crimp impressions were visible on the exposed balloon surface.The balloon folds were partially expanded.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 inflation lumen.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: 7872067
• Report Number: 9612164-2018-02381
• Device Sequence Number: 2061922
• Product Code: NIQ
• UDI-Device Identifier: 00643169557291
• UDI-Public: 00643169557291
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 11/01/2018

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: 10/27/2019
• Device Model Number: RONYX50012UX
• Device Catalogue Number: RONYX50012UX
• Device Lot Number: 0008855956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1