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

Catalog Number	RONYX35034UX
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2018
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 one resolute onyx rx coronary drug eluting stent to treat a lesion.It was reported that a balloon burst occurred.No patient injury was reported.
Additional Manufacturer Narrative
The device was inspected before use with no issues noted.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The target lesion was heavily calcified and in the proximal/mid rca.Negative prep was performed on the device prior to use with no issues noted.Resistance was noted while advancing the device to the lesion.Lesion was not pre-dilated.Excessive force was not used.The device did not pass through a previously deployed stent.The balloon burst occurred on first inflation at 14atm.There was a sudden drop in pressure.The device was not moved or repositioned in the lesion prior to the burst.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: 7994152
• Report Number: 9612164-2018-02869
• Device Sequence Number: 19146336
• Product Code: NIQ
• UDI-Device Identifier: 00643169557123
• UDI-Public: 00643169557123
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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): 12/20/2018

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: 09/28/2019
• Device Catalogue Number: RONYX35034UX
• Device Lot Number: 0008814354
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 10/29/2018; 12/03/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 11/22/2018; 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 75