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

Model Number	RONYX27518UX
Medical Device Problem Codes	Inflation Problem (1310); Activation Problem (4042)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the device was not inspected before use.Negative prep/purging was not performed on the device prior to use.The lesion was pre-dilated using kissing balloons.Inflation difficulties were encountered while trying to deploy the stent.After the resolute onyx was unable to be deployed and removed, the lesion was again pre-dilated.The balloon inflated fully.The stent was post-dilated.The same inflation device was successfully used with other devices.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 a resolute onyx rx coronary drug-eluting stent was used to treat a de novo lesion in the 1st diagonal.It was reported that the stent was unable to be deployed and it was subsequently removed intact.It was then reused, being deployed at 10 atm for 10 seconds.No patient injury 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: 9726325
• Report Number: 9612164-2020-00783
• Device Sequence Number: 16875772
• Product Code: NIQ
• UDI-Device Identifier: 00643169556904
• UDI-Public: 00643169556904
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2020

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: 10/29/2020
• Device Model Number: RONYX27518UX
• Device Lot Number: 0009410979
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 02/25/2020; 04/03/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/18/2020; 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 118