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

Catalog Number RONYX22522UX

Device Problems Break (1069); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Bradycardia (1751); Calcium Deposits/Calcification (1758); Embolism (1829); Low Blood Pressure/ Hypotension (1914); Thrombus (2101); Patient Problem/Medical Problem (2688); Vascular Dissection (3160)

Event Date 06/12/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

During a procedure an attempt was made to use a 2.25 x 38 mm 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 12 mm onyx device was delivered through a 6f launcher guide catheter (ebu375) to treat a lesion in the first diagonal.The 2.25 x 12 mm device was delivered to the target lesion first and then the 2.25 x 38 mm was attempted to be delivered to the proximal to mid lad lesion.During delivery the 2.25 x 38 mm 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 15 mm non-medtronic balloon, a 2.0 x 12 mm euphora 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 12 mm) 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 15 mm onyx proximal to the 2.25 x 38 mm 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 38 mm 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 12 mm euphora balloon and stented over with a 2.5 x 15 mm 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: 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
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7672898
• MDR Text Key: 113513809
• Report Number: 9612164-2018-01678
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RONYX22522UX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention