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

Catalog Number	RONYX27522UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2018
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
Information received from the account on a no cross form stated that the resolute onyx device was damaged.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
The target lesion was in the rca, the lesion was heavily calcified with 90% stenosis and minimum tortuosity.It was subsequently reported that the product was not damaged.The initial information was reported incorrectly.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: 7746685
• Report Number: 9612164-2018-01949
• Device Sequence Number: 1084886
• Product Code: NIQ
• UDI-Device Identifier: 00643169556911
• UDI-Public: 00643169556911
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 10/03/2018

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: 01/06/2020
• Device Catalogue Number: RONYX27522UX
• Device Lot Number: 0008941736
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 08/05/2018; 08/08/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 08/31/2018; 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 81