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

Catalog Number	RONYX35038UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2019
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 the procedure an attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a moderately tortuous and mildly calcified lesion located in the mid lad with 90% stenosis.The device was inspected with no issues noted.Negative prep was not performed.The lesion was pre-dilated using an nc euphora 3.5 x 20mm balloon.The device did pass through a previously-deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that the device was unable to cross the lesion and after it was removed stent deformation was observed, struts had lifted.Another resolute onyx 3.5 x 38mm was deployed with no issues.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation summary: the stent was positioned between the markerbands but not meeting specifications due to deformation of the proximal wraps.Deformation was evident to the 38th 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 hardened blood.There was 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: 8635451
• Report Number: 9612164-2019-01906
• Device Sequence Number: 2387429
• Product Code: NIQ
• UDI-Device Identifier: 00643169557130
• UDI-Public: 00643169557130
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 08/20/2019

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: 03/08/2021
• Device Catalogue Number: RONYX35038UX
• Device Lot Number: 0009633115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1