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

Catalog Number RONYX30012UX

Device Problems Difficult or Delayed Positioning (1157); Device Dislodged or Dislocated (2923)

Patient Problems Embolism (1829); Injury (2348)

Event Date 09/03/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A resolute onyx rx coronary, drug eluting stent was used to treat a moderately calcified and tortuous lesion exhibiting 90% stenosis in the mid left anterior descending (lad) artery.The device was inspected with no issues noted.Negative prep was performed.The lesion was not pre dilated.The device did not pass through a previously deployed stent.Resistance was encountered.Excessive force was used.A launcher guide catheter was used to try and deliver the stent but was not giving adequate support so a telescope guide extension catheter was also used.It was reported that while trying to withdraw the stent from the vessel, a lot of resistance was encountered trying to remove the stent and the guide got pulled into the lad and possibly caught on the stent edge.The resolute onyx dislodged in the ascending aorta.An attempt was made to snare the stent with a 1.5 mm x 10 mm euphora sc which was unsuccessful, and the undeployed stent embolized to a distal vessel in the shoulder area where it was left in the vessel.There is no allegation against either the telescope or launcher device.The patient is alive with no injury.

Manufacturer Narrative

Image review: an image shows a lesion in the proximal lad.There is no dislodged stent visible in the angiographic image.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: 8981250
• MDR Text Key: 157137998
• Report Number: 9612164-2019-03842
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556973
• UDI-Public: 00643169556973
• 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
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2021
• Device Catalogue Number: RONYX30012UX
• Device Lot Number: 0009795433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2019
• Date Device Manufactured: 06/21/2019
• 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