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

Catalog Number RONYX25015UX

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)

Event Date 12/14/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A resolute onyx rx coronary drug eluting stent was attempted to be used to treat a de novo lesion in the proximal rca with 75% stenosis.There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop.It is reported that the device failed to cross the lesion and that a stent dislodgement occurred.The dislodged stent was removed from the patient.A 2.75x22mm resolute was then attempted but also failed to cross.The procedure was completed using a non-medtronic stent.No patient injury is reported.

Manufacturer Narrative

The dislodged stent was crushed in place.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis summary: the stent was not present on the balloon and did not return for analysis.Crimp impressions were visible on the exposed balloon surface.The balloon folds were intact.The inner lumen could not be verified with a 0.015 inch mandrel most likely due to hardened blood in the guidewire lumen.There was no damage evident to the remainder of the device.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: 8185046
• MDR Text Key: 131139389
• Report Number: 9612164-2018-03742
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556805
• UDI-Public: 00643169556805
• 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,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2020
• Device Catalogue Number: RONYX25015UX
• Device Lot Number: 0009113604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2018
• 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