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

Model Number	RONYX40015UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/19/2020
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, an attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a lesion located in the ostium of the left main (lm) coronary artery/ circumflex (cx) artery.The device was inspected with no issues noted.Negative prep was performed with no issues noted.It was reported that stent dislodgement occurred during delivery to/ at the lesion.It was stated that the stent dislodged from the balloon within the lm coronary artery/ ostial left cx.A guide extender was able to advance over the dislodged stent.A 2.0mm balloon was then advanced through the stent and inflated to 6atms at the distal edge with the guide extender.The balloon and guideline device were then removed together with successful retrieval of the dislodged resolute onyx stent.No further patient injury reported.
Additional Manufacturer Narrative
Additional information: an attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a lesion located in proximal lad.The lesion was pre-dilated.The resolute onyx stent did not pass through a previously deployed stent.Resistance was not noted during delivery.Excessive force was not used.Telescope guide extender device.It was later confirmed that there was no issue with the telescope guide extender.Patient was an inpatient at the time of event.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: 10184042
• Report Number: 9612164-2020-02296
• Device Sequence Number: 908759
• Product Code: NIQ
• UDI-Device Identifier: 00643169557161
• UDI-Public: 00643169557161
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2020

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: 01/21/2022
• Device Model Number: RONYX40015UX
• Device Catalogue Number: RONYX40015UX
• Device Lot Number: 0010103357
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 06/23/2020; 07/28/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 07/17/2020; 07/30/2020
• 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