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

Catalog Number	RONYX25008UX
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2018
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
An attempt was made to use two resolute onyx rx coronary drug eluting stents to treat a mildly tortuous and calcified lesion located in the ostium of left main coronary artery and the circumflex (cx) artery.An attempt was first made to use a 4.00x12mm resolute onyx stent.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was not pre-dilated.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.The device did not pass through a previously deployed stent.It was reported that a balloon rupture occurred during stent deployment on the first inflation to 10atm.A non compliant balloon was used to properly deploy the stent.An attempt was then made to use a 2.50x08mm resolute onyx stent.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that a balloon rupture occurred during stent deployment on the first inflation to 8atm.A non compliant balloon was used to properly deploy the stent.The patient is reported to be alive with no injury.
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: 8179071
• Report Number: 9612164-2018-03711
• Device Sequence Number: 19097131
• Product Code: NIQ
• UDI-Device Identifier: 00643169556782
• UDI-Public: 00643169556782
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

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: 05/01/2020
• Device Catalogue Number: RONYX25008UX
• Device Lot Number: 0009094911
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1