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

Model Number	RONYX30015UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: the lesion was moderately tortuous and moderately calcified.The resolute onyx was inspected with no issue.Negative prep was performed with no issue.The device did not pass through a previously-deployed stent.Resistance was noted during delivery.Excessive force was not used.The stent got caught on the calcified lesion during withdrawal.A snare was used to remove the dislodged stent.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 one resolute onyx rx coronary drug eluting stent to treat a lesion.It was reported that that the stent failed to cross the lesion and stent dislodgement occurred.No patient injury was reported.

• 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: 9726881
• Report Number: 9612164-2020-00792
• Device Sequence Number: 2928268
• Product Code: NIQ
• UDI-Device Identifier: 00643169556980
• UDI-Public: 00643169556980
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 04/17/2020

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: 09/01/2021
• Device Model Number: RONYX30015UX
• Device Catalogue Number: RONYX30015UX
• Device Lot Number: 0009902754
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 02/25/2020; 04/16/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/09/2020; 04/17/2020
• 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