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

Catalog Number	RONYX20018UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2019
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 a moderate tortuosity, moderate calcified mid left anterior descending (lad) artery.The device was inspected with no issues.Negative prep was not performed.The lesion was pre dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.It was reported that stent dislodgement occurred during removal following failed delivery.It was reported that the stent never made it to the coronary artery.It was reported that the calcification at subclavian and a balloon in the guide caused the dislodgement.Dislodged stent was removed when removing the guide catheter.It was reported that the stent dislodgement occurred in the guide.It was reported that the patient is alive with no injury.
Additional Manufacturer Narrative
Add info: the subclavian was severely tortuous.There was 90% stenosis in the subclavian which led to a kink in the guide.Resistance was encountered in the subclavian and the resolute onyx was pushed through the kinked area.The 90% stenosis of the subclavian led to kinkage of the guide and dislodgement of the stent.The transradial approach was abandoned and a femoral approach was used to treat the artery.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: 8494581
• Report Number: 9612164-2019-01215
• Device Sequence Number: 1104418
• Product Code: NIQ
• UDI-Device Identifier: 00643169556652
• UDI-Public: 00643169556652
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2019

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: 05/23/2020
• Device Catalogue Number: RONYX20018UX
• Device Lot Number: 0009157654
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1