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

Catalog Number RONYX20030UX

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/15/2019

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 lad.The device was inspected with no issues noted.Resistance was encountered when advancing the device however excessive force was not used.A rotablator was used and an attempt was made to access the lad.It was reported that the stent passed through the lad however became dislodged.An attempt was made to remove the dislodged stent using a snare, but failed.There was no other intervention attempted.The stent remains inside the patient.

• 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: 8353256
• MDR Text Key: 136590137
• Report Number: 9612164-2019-00572
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556683
• UDI-Public: 00643169556683
• 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
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2020
• Device Catalogue Number: RONYX20030UX
• Device Lot Number: 0009136882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2019
• Date Device Manufactured: 05/10/2018
• 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