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	Patient Problem/Medical Problem (2688)
Date of Event	05/15/2018
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
During the procedure an attempt was made to use one resolute onyx drug eluting stent to treat a severely tortuous and severely calcified lesion with 95% stenosis located in the ostium of the circumflex artery.There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop.No difficulties were noted when removing the protective sheath.The device was not inspected.Negative prep was performed with no issues.The lesion was wired and pre-dilated.The inflation device remained on neutral pressure during delivery of the device.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device and excessive force was used during delivery.The device was not kinked and re-straightened during use.The device failed to cross the circumflex artery.It was reported that the stent then dislodged during removal.The stent was crushed against the vessel wall with a different balloon to the delivery system balloon.Patient status 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: 7599948
• Report Number: 9612164-2018-01439
• Device Sequence Number: 1623907
• Product Code: NIQ
• UDI-Device Identifier: 00643169556744
• UDI-Public: 00643169556744
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 10/18/2018

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: 01/09/2020
• Device Catalogue Number: RONYX22526UX
• Device Lot Number: 0008946218
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2018
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 10/18/2018
• 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
• Patient Weight: 109