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

Catalog Number	RONYX45012UX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis summary: there was no deformation evident to the stent wraps and stent strut.The device returned with a detachment on the hypotube 12.65cm distal to the strain relief.A kink was evident on the hypotube 10.5cm distal to the strain relief.The hypotube material was oval and jagged on both sides of the detachment site.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 severely tortuous and calcified lesion exhibiting 80% stenosis.It was informed that the vessel associated with the event was located in the proximal right carotid.There were no abnormalities in relation to anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop/tray.The device was inspected with no issues identified.Negative prep was performed with no issues noted.The lesion was not pre-dilated.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device.Excessive force was used during delivery.It was reported that the catheter shaft kinked and was unable to advance.The device was returned with a detachment on the shaft.It was reported that the catheter broke in the body prior to stent placement.It was removed from the body without any complications.Patient status post-procedure is alive with no injury.
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.

• 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: 7672769
• Report Number: 9612164-2018-01676
• Device Sequence Number: 11112133
• Product Code: NIQ
• UDI-Device Identifier: 00643169557239
• UDI-Public: 00643169557239
• 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): 10/05/2018

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: 08/23/2019
• Device Catalogue Number: RONYX45012UX
• Device Lot Number: 0008765409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 09/11/2018; 08/08/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 09/14/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR