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

Catalog Number	RONYX35022UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)
Date of Event	12/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a lesion.It was reported that the stent failed to cross the lesion, upon removal stent dislodgment occurred.The dislodged stent was not removed.No patient injury is reported.
Additional Manufacturer Narrative
A right radial approach was used.The target lesion was a highly complex, diffusely diseased, calcified mid circumflex lesion, and had 80-90% stenosis.The lesion was pre-dilated twice using a 2.75x12mm sc balloon.The stenosis was reduced to 75%.Due to significant resistance, a non-medtronic guide extension catheter was used to assist in advancing the resolute onyx.Multiple attempts were made to advance the stent but were unsuccessful.There was significant resistance in the prox cx.It was reported that the stent dislodged from the balloon while withdrawing the device.The undeployed stent was seen in the left main and prox cx.An attempt to retrieve the stent with the stent balloon was unsuccessful.A 1.5x8mm sc balloon was advanced.An attempt to retract the stent into the guide with the balloon was unsuccessful.An attempt to advance the non-medtronic guide extension catheter over the stent was unsuccessful.A 3.0x 12mm sc balloon was then advanced to the mid cx.The balloon was inflated which resulted in the stent being pushed further down towards the stenosis.The stent was then adequately expanded and apposed using multiple inflations with multiple balloons.Another 3.5x12mm resolute onyx was implanted, reducing the stenosis to 0%.Post dilation was performed.Repeat angiography revealed excellent angiographic results.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: 8221355
• Report Number: 9612164-2019-00069
• Device Sequence Number: 197311
• Product Code: NIQ
• UDI-Device Identifier: 00643169557093
• UDI-Public: 00643169557093
• 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
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2019

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: 07/07/2020
• Device Catalogue Number: RONYX35022UX
• Device Lot Number: 0009222058
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/26/2018
• Supplement Date Received by Manufacturer: 01/04/2019; 03/14/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 01/29/2019; 03/19/2019
• 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