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

Model Number	RONYX20022UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2018
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
During the procedure, an attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a mildly tortuous and non-calcified lesion located in the mid ramus.There were no abnormalities reported in relation to the anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated.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 an attempt was made to pass the device distal to a previously deployed stent and stent deformation occurred in vivo.No patient injury reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation: the stent was positioned on the balloon between the marker bands as per specifications.Misalignment was evident to the 1st distal stent wraps with struts raised.Deformation was evident to the distal tip.The 0.015 inch mandrel would not load through the guidewire lumen due to hardened blood on the catheter.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: 7809071
• Report Number: 9612164-2018-02143
• Device Sequence Number: 11091112
• Product Code: NIQ
• UDI-Device Identifier: 00643169556669
• UDI-Public: 00643169556669
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 11/07/2018

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: 01/27/2020
• Device Model Number: RONYX20022UX
• Device Lot Number: 0008972307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 09/20/2018; 11/06/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 10/18/2018; 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 87