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

Catalog Number	RONYX30038W
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2018
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
One resolute onyx drug eluting stent was intended to be used to treat a severely calcified lesion in the rca with 80% diffuse mid-artery occlusion with thrombosis.The device was inspected with no issues.The lesion was pre-dilated with a 2.0mm x 20mm balloon.Resistance was encountered when advancing the device and excessive force was used.It was reported that the stent failed to cross the lesion and when removed was noted to be deformed.The lesion was then pre-dilated with a 3.0mm x 20mm balloon, guideliner was advanced and a 3.0mm x 38mm onyx stent was successfully placed followed by a more proximal 3.0mm x 38mm onyx stent and then another 3.50mm x 30mm onyx was placed in the proximal segment in the rca.No patient injury is reported.
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 OTW
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7689038
• Report Number: 9612164-2018-01736
• Device Sequence Number: 1588653
• Product Code: NIQ
• UDI-Device Identifier: 00643169602564
• UDI-Public: 00643169602564
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 10/08/2018

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: 11/28/2019
• Device Catalogue Number: RONYX30038W
• Device Lot Number: 0008895835
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 09/21/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 10/03/2018; 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 114