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

Model Number RONYX25018X

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problems Calcium Deposits/Calcification (1758); No Consequences Or Impact To Patient (2199); Stenosis (2263)

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

Device analysis: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 1st, 2nd and 3rd stent wraps with struts raised and bunched.Deformation was evident to the distal tip.If information is provided in the future, a supplemental report will be issued.

Event Description

During the procedure, an attempt was made to use one resolute onyx drug eluting stent to treat a lesion located in the circumflex artery.The lesion was highly calcified lesion with 80-90% stenosis, and moderate tortuosity.There were no abnormalities in relation to anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop/tray.The device was inspected with no issues identified.Negative prep was performed with no issues noted.The lesion was pre-dilated with a 2.5x15mm sprinter legend balloon.Resistance was noted while advancing the device.Only moderate force was used.It was reported that the stent failed to cross the lesion.The procedure was stopped and the patient was discharged in good condition.Device analysis identified stent deformation.

Manufacturer Narrative

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

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: 7717590
• MDR Text Key: 115254869
• Report Number: 9612164-2018-01853
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2018
• Device Model Number: RONYX25018X
• Device Catalogue Number: RONYX25018X
• Device Lot Number: 0008069400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/26/2018
• Initial Date FDA Received: 07/25/2018
• Supplement Dates Manufacturer Received: 09/13/2018; 08/08/2018
• Supplement Dates FDA Received: 09/27/2018; 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2016
• 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: 63 YR