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

Catalog Number	RONYX22538UX
Health Effect - Clinical Codes	Arrhythmia (1721); Bradycardia (1751); Embolism (1829); Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Thrombus (2101); Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688); Vascular Dissection (3160)
Date of Event	06/12/2018
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
During a procedure an attempt was made to use a 2.25 x 38mm resolute onyx device to treat a moderately tortuous and calcified lesion with 90% stenosis located in the proximal to mid lad.There was no damage noted to the device packaging.There were no issues removing the device from the hoop.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was used.Simultaneously, a 2.25 x 12mm onyx device was delivered through a 6f launcher guide catheter (ebu375) to treat a lesion in the first diagonal.The 2.25 x 12mm device was delivered to the target lesion first and then the 2.25 x 38mm was attempted to be delivered to the proximal to mid lad lesion.During delivery the 2.25 x 38mm device became wedged in the calcified mid lad.When an attempt was made to withdraw the device the stent dislodged.The dislodged stent was dilated (using a 1.5 x 15mm non-medtronic balloon, a 2.0 x 12mm euphoria balloon and a 2.75 mm non-medtronic nc balloon) and deployed.The stent that was delivered but not deployed in the first diagonal (2.25 x 12mm) was subsequently removed and inspected and the stent was seen to be still mounted on the balloon.After deploying the dislodged stent, a 2.25 x 22 mm onyx was successfully delivered through a 6f guideliner to the mid lad (distal part of the residual lesion).When the wire was pulled back, a proximal lad dissection was noted.It was indicated that the dissection was caused by the deployment of the stent and manipulation of devices proximal to the stent.The dissection was successfully treated by deploying a 2.75 x 15mm onyx proximal to the 2.25 x 38mm device.After finishing the lad pci, the wire was removed and a dislodged stent or a piece of the original dislodged stent was noticed at the tip of the guide catheter.Images showed that a stent piece migrated into the proximal cx.It was reported that a segment of the 2.25 x 38mm device had broken off and was in the proximal lad and that during an attempt to snare the segment it moved to the proximal lcx.The segment was crushed in place using a 2.5 x 12mm euphoria balloon and stented over with a 2.5 x 15mm onyx.This reduced the stenosis in the proximal lcx from 60% to 0%.Pci was performed on the lesion in the proximal 1st diagonal using a euphora balloon and stenosis was reduced from 80% to 20%.During removal of the wire from the lcx a thrombus was noted to have closed the om1.The cause of the thrombus is unknown but it is indicated that it might have migrated from the proximal lad while trying to retrieve the dislodged stent.The om1 was wired and the thrombus successfully removed with a non-medtronic extraction catheter.Flow was restored and the case was finished.No further patient injury is reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
When the lad became dissected and closed the patient became bradycardia and hypotensive and also developed atrial fibrillation.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: 7672884
• Report Number: 9612164-2018-01677
• Device Sequence Number: 11151492
• Product Code: NIQ
• UDI-Device Identifier: 00643169556775
• UDI-Public: 00643169556775
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/09/2018

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: 09/30/2019
• Device Catalogue Number: RONYX22538UX
• Device Lot Number: 0008813021
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 10/15/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 10/03/2018; 11/09/2018
• 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