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

Catalog Number	RONYX22530UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	03/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An attempt was made to use one resolute onyx drug eluting stent to treat a severely tortuous and severely calcified lesion, located in the mid diagonal branch, exhibiting 100% stenosis (cto).There was no damage noted to packaging.There were no issues noted when removing the device from the hoop.There were no difficulties removing the protective sheath.The device was inspected with no issues identified.The lesion was pre-dilated.There was no issue with the inflation device.The device did 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 the stent dislodgement occurred during delivery.It was reported that the device went over a bend and when it was backed up, the stent dislodged, and a non-compliant post dilation balloon was then used to fully expand the stent to the vessel wall.The stent was not crushed.The procedure was completed.Patient status post-procedure is alive with no injury.
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: 7410610
• Report Number: 9612164-2018-00671
• Device Sequence Number: 1373402
• Product Code: NIQ
• UDI-Device Identifier: 00643169556751
• UDI-Public: 00643169556751
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Report Date (Section B): 08/14/2018

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: 08/29/2019
• Device Catalogue Number: RONYX22530UX
• Device Lot Number: 0008772717
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 08/14/2018
• 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: Required Intervention