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

Catalog Number	RONYX30034UX
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2019
Type of Reportable Event	Malfunction
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 non tortuous, moderately calcified lesion with 70% stenosis in the proximal left anterior descending (lad) artery.The device was inspected with no issues.Negative prep was performed with no issue noted.The lesion was predilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It is reported that stent deformation occurred in vivo during positioning/advancement.It is stated that the physician put the stent in and realised it was a little short and when removing the device a strut was noted to be lifted on one end.No patient injury is reported.
Additional Manufacturer Narrative
Add info: the stent was not shorter than indicated on packaging.The 34mm resolute onyx stent was chosen, but a 38mm stent was required.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: the stent was positioned between the markerbands but not meeting specifications due to deformation of the proximal wraps.Deformation was evident from the 29th to 34th distal stent wraps with struts raised, bunched, and overlapping.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 hardened 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: 8513209
• Report Number: 9612164-2019-01320
• Device Sequence Number: 2817020
• Product Code: NIQ
• UDI-Device Identifier: 00643169557031
• UDI-Public: 00643169557031
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2019

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: 04/09/2020
• Device Catalogue Number: RONYX30034UX
• Device Lot Number: 0009076599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 04/15/2019; 05/20/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 05/08/2019; 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR