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

Catalog Number	RONYX40030UX
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2019
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
During a procedure, an attempt was made to use a resolute onyx rx coronary drug eluting stent to treat a severely tortuous and calcified lesion exhibiting 99% stenosis located in the mid circumflex (cx) artery.The device was inspected with no issues noted.Negative prep was performed without issue.The lesion was pre-dilated and rotoblated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.It was reported that there were inflation difficulties during stent deployment.It was indicated that there was a leak in the balloon prior to attempting to inflate the device and the stent delivery system balloon was noted to have a hole in it.It was indicated that the hole may have been caused from either sharp plaque or occurred when loading it.It was reported that small pressure was noted from the start of inflation therefore the inflator was pushed as fast as possible allowing enough pressure to get the stent off the balloon.The patient was reported to be alive with no injury.
Additional Manufacturer Narrative
Additional info: a non-medtronic pre-dilation balloon would not inflate in the lesion.The back of a 300cm non-medtronic guide wire was cut to length 180cm prior to loading the resolute onyx on the guidewire.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: 8436505
• Report Number: 9612164-2019-00947
• Device Sequence Number: 19279058
• Product Code: NIQ
• UDI-Device Identifier: 00643169557208
• UDI-Public: 00643169557208
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 04/18/2019

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: 03/25/2020
• Device Catalogue Number: RONYX40030UX
• Device Lot Number: 0009048180
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1