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

Model Number	RONYX27515UX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2019
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 mildly tortuous, moderately calcified lesion exhibiting 90% stenosis located in the mid-proximal circumflex (cx) artery.The device was inspected with no issues noted.Negative prep was not performed.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the stent.Excessive force was not used.The device was not kinked and re-straightened during use.It was reported that a detachment occurred at the catheter during delivery through the vessel.The detached portion was removed through the guide catheter.The patient was reported to be alive with no injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: there was a detachment on the hypotube 22.6cm distal to the strain relief.Kinks were evident on the hypotube, tactile testing confirmed kinks.The hypotube material was oval and jagged on both sides of the detachment site.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: 9361618
• Report Number: 9612164-2019-04859
• Device Sequence Number: 11414763
• Product Code: NIQ
• UDI-Device Identifier: 00643169556898
• UDI-Public: 00643169556898
• 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): 02/13/2020

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: 05/25/2021
• Device Model Number: RONYX27515UX
• Device Catalogue Number: RONYX27515UX
• Device Lot Number: 0009756020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 01/06/2020; 02/03/2020
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 01/30/2020; 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1