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

Catalog Number	RONYX25034UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/15/2019
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 an attempt was made to use a resolute onyx rx coronary drug eluting stent to treat a mildly calcified and tortuous lesion located in the mid right coronary artery (rca).There was no damage noted to the packaging or any issues noted when removing from the hoop.The device was inspected prior to use.The device passed though a previously deployed stent.There was no resistance encountered when advancing the device and excessive force was not used during delivery of the device.It was reported that the stent dislodged while attempting to advance down the artery.The dislodged stent was removed using a snare.The procedure was completed using a 2.5x18mm and 2.5x23mm non-medtronic stent.The patient was reported to be in a stable condition with no further injury reported.
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: 8460433
• Report Number: 9612164-2019-01083
• Device Sequence Number: 16908538
• Product Code: NIQ
• UDI-Device Identifier: 00643169556850
• UDI-Public: 00643169556850
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 04/29/2019

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: 03/06/2020
• Device Catalogue Number: RONYX25034UX
• Device Lot Number: 0009024511
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 04/29/2019
• 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