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

Catalog Number	RONYX40038UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/27/2018
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
It is reported that a resolute onyx drug eluting stent dislodged within the body during a procedure.A ct confirmed that the stent had migrated to the right calf but did not require retrieval.
Additional Manufacturer Narrative
Corrected data: corrected to be malfunction.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the patient had presented with non-stemi.The prox lad had 80% stenosis with timi 3.The mid lcx had 80% stenosis, followed by the om branch lesion with 90% stenosis.The rca has under deployed stents in the mid to distal segment, and 90% stenosis new lesions with timi 3 flow.The stent dislodged from the stent delivery system.The stent was stripped at the guide when trying to remove after it failed to cross the lesion.The guide wire, guide catheter and dislodged stent (wire floating on wire) were retracted to the sheath site however the stent migrated to the patients calf and was not retrieved.The rca was engaged with a 6f al 1.5 guide.The rca was pre-dilated with a 4mm balloon.Pci of mid-distal rca was performed with 5.0x22mm resolute onyx, 5.0x26mm resolute onyx, and 5.0x30mm resolute onyx overlapping.There was no residual stenosis, timi 3 flow without evidence of dissection or distal embolization.The stents were appropriately sized and well expanded.Pci of lcx was performed with three non-medtronic stents.The patient tolerated the procedure well and is fine.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: 7517587
• Report Number: 9612164-2018-01094
• Device Sequence Number: 1224679
• Product Code: NIQ
• UDI-Device Identifier: 00643169557222
• UDI-Public: 00643169557222
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Risk Manager
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 01/05/2020
• Device Catalogue Number: RONYX40038UX
• Device Lot Number: 0008941752
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 04/17/2018; 06/04/2018; 09/19/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 05/16/2018; 07/02/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1