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

Model Number	RONYX20022UX
Medical Device Problem Codes	Burst Container or Vessel (1074); Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The inflation difficulty occurred during the first inflation attempt.There was zero inflation noted.The device was not moved or repositioned in the lesion.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.
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.The device was inspected with no issues noted.Negative prep was not performed.The lesion was pre-dilated.It was reported that during stent deployment an attempt was made to inflate the stent delivery balloon and it was noted that it was unable to inflate.The balloon was also noted to rupture.The stent and delivery system were removed successfully from the patient without issue or harm.The patient was reported to be alive with no injury.

• 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: 9232658
• Report Number: 9612164-2019-04492
• Device Sequence Number: 2523940
• Product Code: NIQ
• UDI-Device Identifier: 00643169556669
• UDI-Public: 00643169556669
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/24/2020

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: 04/29/2021
• Device Model Number: RONYX20022UX
• Device Catalogue Number: RONYX20022UX
• Device Lot Number: 0009717064
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 10/25/2019; 01/23/2020
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 11/20/2019; 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1