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

Model Number RONYX35008UX

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a procedure an attempt was made to use a resolute onyx rx coronary drug eluting stent to treat a lesion.It is reported that the stent failed to cross the lesion and fractured in two.No patient injury is reported.

Manufacturer Narrative

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: 8098603
• MDR Text Key: 128207236
• Report Number: 9612164-2018-03318
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557055
• UDI-Public: 00643169557055
• Combination Product (y/n): N
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2020
• Device Model Number: RONYX35008UX
• Device Catalogue Number: RONYX35008UX
• Device Lot Number: 0009004442
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2019
• Date Device Manufactured: 02/21/2018
• 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 Age: 62 YR