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

Catalog Number	RONYX20026UX
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure one resolute onyx rx coronary drug eluting stent was used to treat a lesion.It was reported that stent dislodgement occurred during delivery to/at the lesion.No patient injury is reported.
Additional Manufacturer Narrative
The device was being used to treat a non-tortuous lesion.There were no difficulties noted when removing the protective sheath.The device was inspected before use with no issues noted.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.The stent dislodgement occurred in the aorta.The distal portion of the dislodged stent was crushed against the vessel wall in the ostium of the rca using another medtronic drug eluting stent.No additional patient injury is reported.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Image review: the images capture the rca and r-dpa, with a possible lesion site visible in the r-pda.Pre-dilation of the r-pda is visible with an unidentified balloon.The next image captures the dislodged stent.There were no images capturing the attempted delivery of the resolute onyx 2.0x26mm device and subsequent removal of the delivery system after dislodgement.The proximal section of the dislodged stent appears to be stretched and deformed in the aorta.The distal section of the dislodged stent appears to be stretched into the ostium of the rca.A stent device is used to crush the dislodged stent against the wall of the rca.The next images capture further treatment of the vessel, and the distal section of the dislodged stent is visible in the deployed stent.A stent is then deployed in the r-pda.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: 8132235
• Report Number: 9612164-2018-03472
• Device Sequence Number: 1913298
• Product Code: NIQ
• UDI-Device Identifier: 00643169556676
• UDI-Public: 00643169556676
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2020
• Device Catalogue Number: RONYX20026UX
• Device Lot Number: 0009012788
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 12/10/2018; 02/13/2019
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 01/03/2019; 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 62