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

Catalog Number	RONYX22508UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2018
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
The physician intended to use a resolute onyx drug eluting stent to treat a severely tortuous, moderately calcified lesion with 90% stenosis in the proximal lad.There was no damage noted to the device packaging.There were no issues when removing the device from the hoop.No difficulties were noted when removing the protective sheath.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.A 0.014 wire was used.The device passed through a previously deployed stent.The inflation device remained on neutral pressure during delivery of the device.Resistance was encountered when advancing the device.It is reported that the device could not pass through the lesion and when the physician pulled the un-deployed stent back in the unknown brand guide catheter, it caught on the guide catheter tip and dislodged.The stent ended up distal in the periphery.No intervention was carried out.The stent was not crushed or snared.The stent remains in the patient.No patient injury is reported.
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: 7384491
• Report Number: 9612164-2018-00610
• Device Sequence Number: 1067884
• Product Code: NIQ
• UDI-Device Identifier: 00643169556690
• UDI-Public: 00643169556690
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/05/2018

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: 11/17/2019
• Device Catalogue Number: RONYX22508UX
• Device Lot Number: 0008886151
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 07/11/2018; 08/08/2018
• Initial Report FDA Received Date: 03/30/2018
• Supplement Report FDA Received Date: 08/08/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1