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

Model Number	RONYX35030UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Resistance was noted while advancing the device to the lesion and excessive force was not used.The patient was reported to be alive with no injury.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation summary: the stent was positioned on the balloon between the marker bands but not meeting specifications due to deformation of the distal stent wraps.Deformation was evident to a distal stent wrap with struts raised.A protective sheath of similar dimensions to that used during the manufacturing of this batch, could be placed over the stent.No other damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure it was intended to use a resolute onyx rx coronary drug eluting stent.There was no damage noted to the packaging and no issues noted when removing the device from the hoop.The protective sheath on the stent, when the device was removed from hoop.No resistance was encountered when removing the sheath.The sheath was gripped on the most distal end of the sheath during removal from over the stent/balloon.The stent was inspected post sheath removal with no abnormalities noted.The stent was not handled directly post removal of the sheath.It was reported that the stent was noticed to have issues after it was attempted to be delivered to the lesion and was pulled out of the body.It was reported that the stent had damage on its end, the end of the stent was noted to have burrs.

• 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: 9537712
• Report Number: 9612164-2020-00022
• Device Sequence Number: 11346525
• Product Code: NIQ
• UDI-Device Identifier: 00643169557116
• UDI-Public: 00643169557116
• 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
• 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: 02/24/2020
• Device Model Number: RONYX35030UX
• Device Catalogue Number: RONYX35030UX
• Device Lot Number: 0009009968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1