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

Model Number	RONYX20026UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2020
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 one resolute onyx rx coronary drug eluting stent to treat a lesion located in the second diagonal branch.It was reported that stent dislodgement occurred.It was stated that the stent fell of the guider.It is unknown if the stent dislodgement occurred in vitro or in vivo.No patient injury was reported.
Additional Manufacturer Narrative
Initial reporter name added.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.
Additional Manufacturer Narrative
Additional information: a photograph of the front face of a resolute onyx shelf carton.The device size and lot number correspond with the information reported.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: 9716194
• Report Number: 9612164-2020-00740
• Device Sequence Number: 11580776
• Product Code: NIQ
• UDI-Device Identifier: 00643169556676
• UDI-Public: 00643169556676
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 04/15/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2020
• Device Model Number: RONYX20026UX
• Device Catalogue Number: RONYX20026UX
• Device Lot Number: 0009146776
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 02/10/2020; 03/27/2020; 04/14/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 03/06/2020; 03/30/2020; 04/15/2020
• 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: Other