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

Model Number	RONYX50018UX
Medical Device Problem Codes	Burst Container or Vessel (1074); Inflation Problem (1310); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2018
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
During the procedure, an attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a mildly tortuous and severely calcified lesion located in the mid rca.There were no abnormalities in relation to the anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was not pre-dilated.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device.It was reported that during positioning the stent catheter was severely kinked and when an attempt was made to deploy the stent inflation difficulties were encountered during the first inflation.The balloon was only able to be inflated to 2 atm regardless of how many attempts were made to deliver more pressure.The proximal and distal portions of the stent flared at 2 atm.It was suggested that balloon burst/leak occurred.The stent was therefore unable to be deployed.The wire, stent and guider were then all removed at once and the stent was not on the balloon after removal of all products and appears to have dislodged.The stent was not visualized under fluoroscopy following removal.It is unknown if the stent was left in the body.No patient injury was reported.
Additional Manufacturer Narrative
The device returned with a detachment on the hypotube.It was reported that the detachment occurred upon removal of the device.Device evaluation: a stopcock was attached to the luer of the device.The stent was not present on the balloon and did not return for analysis.Crimp impressions were visible on the exposed balloon surface.The balloon folds were partially expanded.The inner lumen patency could not be verified with a 0.015 inch mandrel most likely due to hardened blood in the inflation lumen.The delivery system returned with a detachment on the hypotube 28.9cm distal to the strain relief.The hypotube material was oval and jagged on both sides of the detachment site.Kinks were evident on the hypotube 2cm proximal and distal to the detachment site.Deformation was evident to the distal tip.The hypotube was cut immediately distal to the kink in order to attach a makeshift luer to aid inflation.The balloon returned with blood visible in the balloon and inflation lumen.The delivery system was placed in the waterbath to disperse the blood in the balloon and inflation lumen in order to aid inflation.The balloon passed negative prep.On pressurisation of the delivery system the balloon inflated.The balloon-maintained pressure.The inner distal appeared to be deformed with the material appearing bow shaped.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.

• 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: 7859185
• Report Number: 9612164-2018-02333
• Device Sequence Number: 1980595
• Product Code: NIQ
• UDI-Device Identifier: 00643169557314
• UDI-Public: 00643169557314
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup
• Report Date (Section B): 01/28/2019

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: 03/03/2020
• Device Model Number: RONYX50018UX
• Device Lot Number: 0009020349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 10/10/2018; 01/28/2019; 01/28/2019
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 10/15/2018; 01/28/2019; 01/28/2019
• 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