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

Catalog Number	RONYX22534UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	08/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cine image review: review of the procedural images confirmed the difficult nature of the vessel/lesion morphology.The images capture the attempted delivery of the stent.The dislodged stent is visible on the guidewire at the tip of the guide catheter.The proximal stent wraps appear to be deformed and bunched.An unidentified stent is subsequently deployed at the lesion site.
Event or Problem Description
It was reported that during use of a resolute onyx drug eluting stent that the stent dislodged.The target lesion located in the mid rca had moderate calcification, mild tortuosity with exhibited 80% stenosis.There were no issues reported on removing the device from the hoop or removing the protective sheath.The device was inspected with no issues noted with negative prep performed with no issues reported.The lesion was pre-dilated and the device did not pass through a previously deployed stent.Resistance was encountered when advancing the device however no excessive force was exerted.It was reported that the stent dislodged when pulling back/withdrawing the device.The dislodged stent was removed using a snare.No patient injury reported.
Additional Manufacturer Narrative
(b)(4).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: 6914065
• Report Number: 9612164-2017-01362
• Device Sequence Number: 1041540
• Product Code: NIQ
• UDI-Device Identifier: 00643169556768
• UDI-Public: 00643169556768
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/26/2019
• Device Catalogue Number: RONYX22534UX
• Device Lot Number: 0008471150
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 10/04/2017
• Supplement Report FDA Received Date: 11/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention