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

Catalog Number	RONYX22526UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Death (1802)
Date of Event	09/24/2018
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 the procedure a resolute onyx rx coronary drug eluting stent was used to treat a lesion in the cx artery.It was reported that stent dislodgement occurred in the left main artery during removal following a failed delivery.The device was not removed from the patient and the patient was sent to the operating room for grafting.It was reported that the patient expired on the (b)(6) 2018.
Additional Manufacturer Narrative
The device was being used to treat a lesion in the mid left cx, with stenosis of greater than 90%.There was also approximately 80% stenosis in the mid lad.There were no difficulties noted when removing the protective sheath.The device was inspected post removal of the sheath with no issues.The lesion was pre-dilated.The inflation device remained on neutral pressure during device delivery.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device, but excessive force was not used.The stent dislodgement occurred in the left main artery, proximal to the lesion.The stent had failed to cross the lesion.The stent came off the catheter while trying to pass through the lesion for placement.Another balloon was used and stent was ultimately retained in the vessel.The patient was sent to the or for emergency bypass grafting.The patient had no previous stents.The patient had no previous pcis.The patient was not on dapt at the time of the event.There was no evidence of restenosis or thrombus.The cause of death was cardiac arrest.At the time of death the patient had co-morbidities of hyperlipidemia and obesity.The physician assessed that the stent being retained in the vessel is why the patient went to the or, but cannot confirm that the event ultimately lead to the death of the patient.If information is provided in the future, a supplemental report will be issued.
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: 7955423
• Report Number: 9612164-2018-02710
• Device Sequence Number: 1311457
• Product Code: NIQ
• UDI-Device Identifier: 00643169556744
• UDI-Public: 00643169556744
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/22/2020
• Device Catalogue Number: RONYX22526UX
• Device Lot Number: 0009046168
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 12/10/2018; 02/08/2019
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 01/03/2019; 02/11/2019
• 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: 77 YR
• Patient Weight: 84