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

Model Number	RONYX35018UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Negative prep/purging was not performed on the device prior to use.The lesion was predilated.The device did not pass through a previously deployed stent or cell of a stent.Resistance was noted while advancing the device to the lesion.Excessive force was not used.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 moderately tortuous, moderately calcified lesion exhibiting 99% stenosis in the mid right coronary artery (rca).There was no damage noted to the packaging or any issues noted when removing the device from the hoop.The device was inspected with no issues noted.It was reported that stent deformation occurred in vivo during positioning.The patient was reported to be alive with no injury.
Additional Manufacturer Narrative
Product analysis summary: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the distal stent wraps with struts raised.No deformation was evident to the distal tip.The inner lumen patency could not be verified with a 0.015 inch mandrel most likely due to harden blood in the guidewire lumen.No other damage evident to the remainder of the device.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: 9435961
• Report Number: 9612164-2019-05044
• Device Sequence Number: 2387645
• Product Code: NIQ
• UDI-Device Identifier: 00643169557086
• UDI-Public: 00643169557086
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/17/2020

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: 07/13/2020
• Device Model Number: RONYX35018UX
• Device Catalogue Number: RONYX35018UX
• Device Lot Number: 0009235387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 12/10/2019; 01/30/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 12/12/2019; 02/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 42