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

Model Number	RONYX22512UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Thrombosis (2100)
Date of Event	01/15/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure one resolute onyx rx was implanted in the mid diagonal branch.The lesion was moderately tortuous and moderately calcified with 90% stenosis.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was not pre-dilated.The device did pass through a previously deployed stent.No resistance was encountered when advancing the device and excessive force was not used during delivery.There were no issues noted during stent deployment and the stent was fully expanded.It was reported that stent thrombosis occurred 0-24 hours post implantation.It is unknown if the patient was on dapt, however angiomax was used during the procedure.The thrombus was not treated.Patient death occurred on the same day due to heart failure.It is unknown if the resolute onyx device contributed to patient death.
Additional Manufacturer Narrative
Additional information: cine images were returned for evaluation.Plad/dx1 a two stent bifurcated lesion with in-stent restenosis on dx1 stent, heavily calcify lesion.Dx1 in-stent restenosis revasac with 2 guidewires, balloon used 5 times with same gain in lumen diameter.Microcirculatory dysfunction and impella support left circumflex artery with chronic total occlusion, graft occluded.Post coronary artery bypass graft, right coronary artery, right internal mammary artery (rima) to distal right coronary artery, rima with two stents.Patient unstable during procedure (atrial fibrillation with rapid ventricular response 120 hr).No intravascular imaging used.Right after procedure patient became unresponsive, ventricular fibrillation, code started, ecg no acute changes, left ventricular ejection fraction 35%.Impella on, potential use of extracorporeal membrane oxygenation, but ventricular fibrillation with no pulse.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The patient received iv heparin pre-procedure.Upon wiring the diagonal branch, without any intervention, the patient was noted to have developed atrial fibrillation.The vessel was post-dilated using a non-medtronic nc balloon.Post procedure the patient went in to ventricular fibrillation, was bradycardic, and pulseless.Patient received cpr and was defibrillated multiple times.Patient received heart pump but adequate flow was not restored.Further angiography was performed, during which, a 6fr export catheter was inserted but was unable to be delivered.Flow was restored to the apical lad and right heart catheterisation performed.Patient developed several more episodes of ventricular fibrillation requiring defibrillation.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: 9710826
• Report Number: 9612164-2020-00723
• Device Sequence Number: 11537818
• Product Code: NIQ
• UDI-Device Identifier: 00643169556706
• UDI-Public: 00643169556706
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/02/2021
• Device Model Number: RONYX22512UX
• Device Catalogue Number: RONYX22512UX
• Device Lot Number: 0009949751
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 04/03/2020; 04/17/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 04/09/2020; 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 70 YR
• Patient Weight: 68