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

Catalog Number	RONYX35038UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A resolute onyx rx coronary, drug eluting stent was used to treat a severely tortuous, severely calcified lesion exhibiting 80% stenosis in the proximal right coronary artery (rca).The device was inspected with no issues noted.Negative prep was not performed.The lesion was pre dilated.The device did not pass through a previously deployed stent.Resistance was encountered.Excessive force was not used during delivery.It was reported that the stent became dislodged inside the guide liner extension catheter during delivery to/at the lesion.The stent was able to be retrieved.The patient is alive with no injury.
Additional Manufacturer Narrative
It was reported that an attempt to deliver the resolute onyx was unsuccessful.A non-medtronic guide extension catheter (gec) was inserted.Another attempt was made to deliver the resolute onyx, but was unsuccessful.The vessel was dilated with a non-compliant balloon.The non-medtronic gec was removed and another non-medtronic gec was inserted.The stent was not on the balloon when the device exited the gec.The stent was able to be retrieved from the gec.Another brand stent was successfully deployed.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: 8939001
• Report Number: 9612164-2019-03613
• Device Sequence Number: 19472705
• Product Code: NIQ
• UDI-Device Identifier: 00643169557130
• UDI-Public: 00643169557130
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2021
• Device Catalogue Number: RONYX35038UX
• Device Lot Number: 0009765659
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 08/29/2019; 10/14/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 09/25/2019; 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR