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

Catalog Number	RONYX50012UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/19/2019
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 a procedure a resolute onyx rx coronary drug eluting stent was intended to be used to treat a right coronary artery (rca).The device was inspected with no issues noted.Negative prep was not performed.The device did not pass through a previously deployed stent.Resistance was not encountered.Excessive force was not used during delivery.It was reported that the stent dislodged during delivery to the lesion.The stent was located in the sublclavian and snared back to the axillary artery and deployed.It was noted that there was a lot of cardiac motion while deploying the stent and rca takeoff was not normal.The patient is alive with no injury.
Additional Manufacturer Narrative
The target lesion was pre-dilated.There was no tortuosity or calcification.The lesion was a 100% occluded-thrombotic lesion in a s temi patient.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: 8721783
• Report Number: 9612164-2019-02471
• Device Sequence Number: 2021971
• Product Code: NIQ
• UDI-Device Identifier: 00643169557291
• UDI-Public: 00643169557291
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2019

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: 02/05/2020
• Device Catalogue Number: RONYX50012UX
• Device Lot Number: 0008982752
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 08/08/2019
• 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: Required Intervention