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

Model Number	RONYX25012UX
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Thrombus (2101); Injury (2348)
Date of Event	02/06/2020
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 a resolute onyx rx coronary drug eluting stent to treat a moderately tortuous, severely calcified lesion exhibiting 85% stenosis in the mid circumflex (cx) artery.There was no damage noted to the packaging or any issues noted when removing the device from the hoop.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device.It was reported that stent dislodgement occurred during delivery to/at lesion.Stent was eventually expanded into place with a smaller balloon.It was stated that the patient came back next day with stent thrombosis.It was also mentioned that the stent could be undersized.The patient was reported to be alive with no further injury.
Additional Manufacturer Narrative
Stent was eventually expanded into place with a 1.5mm balloon.The patient was on dapt at the time of the event.The thrombus was treated with medication.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Cine image review: an angiographic photo provided confirms a stent thrombosis in the lcx.There are no images provided of the reported stent dislodgement.It is not possible to determine from the images if the stent was undersized as reported from the account.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: 9693160
• Report Number: 9612164-2020-00666
• Device Sequence Number: 16580211
• Product Code: NIQ
• UDI-Device Identifier: 00643169556799
• UDI-Public: 00643169556799
• 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
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2020

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: 09/29/2021
• Device Model Number: RONYX25012UX
• Device Catalogue Number: RONYX25012UX
• Device Lot Number: 0009945934
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 02/13/2020; 04/06/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/02/2020; 04/16/2020
• 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
• Patient Age: 75 YR
• Patient Weight: 105