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

Catalog Number	RONYX35022UX
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
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 severely tortuous, mildly calcified lesion exhibiting 95% stenosis in the mid right coronary artery (rca).The device was inspected with no issues.Negative prep was not performed.The lesion was pre dilated using a 2.0x15mm euphora balloon.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.The mid rca lesion had severe angulation proximal to the stenosis.It was reported that an attempt was made to advance the stent and it would not cross just proximal to the stenosis.The undeployed stent was pulled back into the 6f guide catheter and resistance was met when the stent was half way into the guide catheter.The resistance prevented the device from being pulled back so all the devices were removed together.On inspection it was noted that some of the struts were lifted and deformed which prevented the stent from been fully retrieved inside the guide.The patient is alive with no injury.
Additional Manufacturer Narrative
Evaluation summary: the device returned loaded in to a guide catheter, a y-connector was loaded on the device and a guide wire was loaded in the device.The distal section of the device had exited the guide catheter.Deformation was evident to the 5th distal stent wraps with struts raised and stretched.Due to the deformed stent struts it was not possible to remove the device from the guide catheter.Od measurement, stent position and patency testing could not be performed due to entrapment of the device.There was no damage noted to the distal tip.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: 8721758
• Report Number: 9612164-2019-02470
• Device Sequence Number: 13934421
• Product Code: NIQ
• UDI-Device Identifier: 00643169557093
• UDI-Public: 00643169557093
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2019

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: 11/05/2020
• Device Catalogue Number: RONYX35022UX
• Device Lot Number: 0009421299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1