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

Catalog Number	RONYX27508UX
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the device was returned with blood visible in the balloon and inflation lumen.The balloon failed negative prep.On pressurisation of the device, water was seen exiting the gw entry port.The balloon failed to maintain pressure.Upon visual inspection of the device, there appeared to be a tear site along the inner lumen.Balloon material was cut away to give a clear image of tear site.Close inspection indicated a radial tear was present along the inner lumen, immediately distal to the distal marker band and 0.4cm proximal to the distal tip.The balloon material was jagged and uneven at the tear site.Due to inflation testing, stent had expanded and come off delivery system.Deformation to the distal tip was visible, tip appeared stubbed.Inner lumen patency was not verified due to tear site.(b)(4).
Event or Problem Description
It was reported that the physician was attempting to use a resolute onyx rx drug eluting stent to treat an ostium rca.No damage to device packaging and no issues removing the device from the hoop/tray.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was not pre-dilated.During the procedure, the device did not pass through a previously deployed stent.No resistance was encountered and no excessive force used.During the first inflation, inflation difficulties were reported during stent deployment at 14atm; the device would not hold inflation.No intervention was required to remove the undeployed resolute onyx stent.The inflation device was successfully used with another device post inflation difficulties.The patient was then treated with multiple resolute onyx stents in rca, in order to stabilize them and transfer them to another hospital for cabg.A total of three stents were implanted, without issue.No patient injury was reported.

• 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: 7174734
• Report Number: 9612164-2018-00036
• Device Sequence Number: 1979090
• Product Code: NIQ
• UDI-Device Identifier: 00643169556874
• UDI-Public: 00643169556874
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 01/09/2018

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: 08/25/2019
• Device Catalogue Number: RONYX27508UX
• Device Lot Number: 0008768974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 60