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

Catalog Number	RONYX30018W
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The physician intended to use a resolute onyx drug eluting stent to treat a mildly tortuous, mildly calcified lesion with 90% stenosis in the mid rca.There was no damage noted to packaging and there were no issues noted when removing the device from the hoop.The device was inspected with no issues.The lesion was pre-dilated.There were no abnormalities reported in relation to anatomy.Resistance was not encountered and excessive force was not used.The device did not pass through a previously deployed stent.It is reported that a balloon leak occurred during negative prep prior to inflation.The stent was positioned over the lesion and not moved/re-positioned prior to the balloon leak.The balloon leak occurred in the patient's vessel.It was reported that negative prep of the device was done in the body and when the tech pulled negative with the indeflator, when the stent was in the artery, blood came back.It is unknown where on the device the leak occurred.The procedure was successfully completed using another onyx device.No patient injury was reported and the patient is currently fine.
Additional Manufacturer Narrative
Image review: review of the procedural images confirm the location of the lesion in the rca vessel.The resolute onyx stent is captured positioned at the lesion site.Balloon inflation was not attempted therefore there is no contrast leak from the guide catheter captured on the images.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: the stent was present on the balloon.The stent was positioned between the marker bands as per specification.The device returned with blood visible in the inflation lumen.The balloon initially passed negative prep.On pressurisation of the device, the balloon would not inflate.The device was left in a water bath for 48 hrs to disperse the contents of the inflation lumen.The device then failed negative prep.Pressure was applied slowly to inflate the balloon to nominal pressure.The balloon partially inflated and the stent expanded.During application of pressure a leak was observed on the catheter at 74.5cm proximal to the distal tip.The leak site showed small tears on the shaft of the device.No deformation to the stent struts.Slight deformation to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.There was a kink in the distal shaft at 57.5cm proximal to the distal tip.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX OTW
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7023905
• Report Number: 9612164-2017-01595
• Device Sequence Number: 1745071
• Product Code: NIQ
• UDI-Device Identifier: 00643169602519
• UDI-Public: 00643169602519
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/03/2018

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: 05/22/2019
• Device Catalogue Number: RONYX30018W
• Device Lot Number: 0008642414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 01/31/2018; 03/07/2018
• Initial Report FDA Received Date: 11/13/2017
• Supplement Report FDA Received Date: 02/28/2018; 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 81