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

Model Number	RONYX30034UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: device was attempted to be used to treat a lesion with severe diffuse stenosis in the lad.The device was inspected before use with no issues.Negative prep was performed.The lesion was pre-dilated.Excessive force was not used.Product analysis summary: the stent was positioned on the balloon between the marker bands as per specifications.Misalignment of stent struts was evident to the 1st distal stent wrap.Deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.No other damage evident to the remainder of the device.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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A resolute onyx coronary drug eluting stent was attempted to be used to treat a lesion.The device passed through a previously deployed stent.Resistance was encountered when advancing the device.It was reported that the device failed to cross the previously implanted stent.When the device was removed it was noted to have some struts lifted.The procedure was completed using another 3.00x34mm resolute onyx stent.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: 9569592
• Report Number: 9612164-2020-00170
• Device Sequence Number: 16914090
• Product Code: NIQ
• UDI-Device Identifier: 00643169557031
• UDI-Public: 00643169557031
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 03/16/2020

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: 07/13/2021
• Device Model Number: RONYX30034UX
• Device Catalogue Number: RONYX30034UX
• Device Lot Number: 0009827068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 01/28/2020; 03/15/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 02/17/2020; 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 83