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

Catalog Number RONYX25022UX

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a mildly tortuous, severely calcified lesion located in the mid circumflex (cx) artery.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.The device was passed through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that when attempting to stent the lesion that the stent caught in a heavily calcified previously stented left main.When attempting to remove the stent the stent was caught in the left main and dislodged off the balloon undeployed.The dislodged stent was removed using a snare.The patient is reported to be alive.There is no additional injury reported post procedure.

Manufacturer Narrative

There were no difficulties when removing the protective sheath.The inflation device was in a neutral position while the stent was being positioned.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis summary: a stop cock was attached to the luer of the delivery system.Dislodged stent returned attached to a snare.Crimp impressions were visible on the exposed balloon surface of the delivery system.The balloon folds remained intact.The inner lumen patency was verified with a 0.015 inch mandrel.Deformation was evident to the distal tip.Deformation was evident to the dislodged stent with the struts stretched.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: 8146681
• MDR Text Key: 129781193
• Report Number: 9612164-2018-03535
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556829
• UDI-Public: 00643169556829
• 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: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: RONYX25022UX
• Device Lot Number: 0008860191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2017
• 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
• Patient Age: 65 YR