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

Catalog Number	RONYX40008UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/30/2018
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 a resolute onyx rx coronary drug eluting stent was used to treat a mildly tortuous, severely calcified lesion exhibiting 99% stenosis located in the left main (lm) coronary artery.The device was inspected with no issues.The lesion was pre-dilated using a 2.5mm balloon.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that while attempting to stent the left main into the lad that the stent was deployed at 18atms.After deploying the stent the balloon was removed and a perforation was observed.An attempt was made to treat the perforation using a stent graft and other balloons; however, were unsuccessful.An attempt was next made to treat the perforation using a 4.00x08mm resolute onyx rx coronary drug eluting stent.The device was inspected with no issues.Negative prep was performed with no issues.It was reported that the 4.00x08mm resolute onyx stent was used in the ostial left main but failed to treat the perforation.The patient is reported to have died on the same day as the procedure.It is indicated that the cause of date was a perforation in the left main.
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: 8159833
• Report Number: 9612164-2018-03607
• Device Sequence Number: 11334698
• Product Code: NIQ
• UDI-Device Identifier: 00643169557147
• UDI-Public: 00643169557147
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 03/11/2019

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: 04/04/2020
• Device Catalogue Number: RONYX40008UX
• Device Lot Number: 0009066096
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 03/11/2019
• 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; Required Intervention
• Patient Age: 75 YR