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

Catalog Number RONYX30030X

Device Problems Use of Device Problem (1670); Device Dislodged or Dislocated (2923)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 09/19/2021

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 lesion in the 1st obtuse marginal.It was reported that after advancing the guide to the lesion it was not possible to advance the stent completely at the lesion.When attempting to remove it, the stent detached from the balloon and remains in the proximal left main (lm) - circumflex (cx) - 1st proximal obtuse marginal.It was stated that there is an imminent need to withdraw the stent.No further patient injury was reported.Although not reported by the account, the stent was noted to be expired at the time of the event.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12561501
• MDR Text Key: 274247448
• Report Number: 9612164-2021-03779
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2021
• Device Catalogue Number: RONYX30030X
• Device Lot Number: 0009802027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2021
• Date Device Manufactured: 06/27/2019
• 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