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

Catalog Number RONYX22538UX

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 during a procedure.The device was inspected with no issues.Negative prep was performed with no issues.It was reported that stent dislodgement occurred during delivery to/at the lesion.The dislodged stent was removed using a snare.

Manufacturer Narrative

There was not a lot of tortuosity or calcification at the lesion.It was indicated that it was not a challenging lesion.No difficulties were noted when removing the protective sheath.The stent was inspected post removal of the protective sheath with no issues noted.The lesion was pre-dilated.The device did not pass through a previously deployed stent or cell of a stent.No significant resistance was noted when advancing the device.Excessive force was not used during delivery.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: 8347034
• MDR Text Key: 136473466
• Report Number: 9612164-2019-00534
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556775
• UDI-Public: 00643169556775
• 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,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2020
• Device Catalogue Number: RONYX22538UX
• Device Lot Number: 0009163133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2019
• Date Device Manufactured: 05/30/2018
• 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