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

Model Number	RONYX27538UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/21/2020
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.It was reported that stent dislodgement occurred during deliver to/at a lesion.It was stated that the stent was removed from the patient.The patient was reported to be alive with no further injury.
Additional Manufacturer Narrative
Product analysis: two images were received for analysis.In both images the dislodged stent is loaded on a wire.Deformation is evident to the dislodged stent.The luer and a section of the delivery system of the resolute onyx device is visible in the second image.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: 10091025
• Report Number: 9612164-2020-01988
• Device Sequence Number: 17029222
• Product Code: NIQ
• UDI-Device Identifier: 00643169556959
• UDI-Public: 00643169556959
• 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
• Report Date (Section B): 07/09/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/03/2021
• Device Model Number: RONYX27538UX
• Device Catalogue Number: RONYX27538UX
• Device Lot Number: 0009765655
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 07/09/2020
• 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: Required Intervention