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

Catalog Number RONYX20012UX

Device Problems Migration or Expulsion of Device (1395); Activation, Positioning or SeparationProblem (2906); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 12/30/2021

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 a resolute onyx coronary drug eluting stent to treat a severely calcified lesion. The device was inspected with no issues. Negative prep was performed with no issues. The device did not pass through a previously deployed stent. Resistance was encountered when advancing the device. Excessive force was not used.  it was reported that stent dislodgement occurred during delivery to the lesion. The stent was deployed at 4 atm, but the stent was not deployed properly and floated in the vessel. The dislodged stent was crushed in the profunda artery. The patient is alive with no further injury.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13235317
• MDR Text Key: 283672513
• Report Number: 9612164-2022-00166
• 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: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: RONYX20012UX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/12/2022 Patient Sequence Number: 1