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

Model Number	RONYX25012UX
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Image analysis summary: an image provided shows the dislodged stent in the inguinal area.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
During the withdrawal of the stent, resistance was noted, but excessive force was not used.The stent migrated to the right inguinal area and it was decided to leave in place.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.
Event or Problem Description
During a procedure an attempt was made to use a resolute onyx rx coronary drug eluting stent to treat a non tortuous and non calcified lesion.The device was inspected with no issues noted.Negative prep was performed without issue.Resistance was not encountered when advancing the device and excessive force was not used during delivery.It was reported that difficulty occurred while attempting to position the stent and upon withdrawal back into the guide, stent dislodgement occurred.It was decided to leave the stent in place in the right femoral area.The patient was reported to be alive with no injury.

• 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: 9537840
• Report Number: 9612164-2020-00024
• Device Sequence Number: 2335099
• Product Code: NIQ
• UDI-Device Identifier: 00643169556799
• UDI-Public: 00643169556799
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 03/27/2020

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: 09/25/2021
• Device Model Number: RONYX25012UX
• Device Catalogue Number: RONYX25012UX
• Device Lot Number: 0009942194
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 01/17/2020; 03/26/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 02/12/2020; 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1