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

Catalog Number RONYX40015UX

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/04/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A resolute onyx 4.00x15mm drug eluting stent was intended to be used during a procedure to treat a lesion in the mid rca, exhibiting mild tortuosity and severe calcification.No damage was noted to the packaging.No issues removing the device from the hoop.Device was inspected with no issues.Negative prep was performed with no issues.Device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.It is reported that stent dislodged during delivery to the lesion.The device was not kinked or re-straightened during use.Multiple non-medtronic balloons were used to push the stent against the wall.The dislodged stent was then successfully covered with a resolute onyx 4.00x22mm.Post timi flow was 3, and lesion was 0% stenosis at the end of the procedure.No issues is reported for the second stent.

• 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: 8309612
• MDR Text Key: 135138805
• Report Number: 9612164-2019-00426
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557161
• UDI-Public: 00643169557161
• 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: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2020
• Device Catalogue Number: RONYX40015UX
• Device Lot Number: 0009006917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2019
• Initial Date FDA Received: 02/06/2019
• Date Device Manufactured: 02/22/2018
• 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
• Patient Weight: 106