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

Catalog Number RONYX25022X

Device Problems Material Deformation (2976); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2018

Event Type  malfunction  

Manufacturer Narrative

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 non-tortuous and severely calcified lesion located in the mid left anterior descending artery, exhibiting 90% stenosis.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues identified.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that the stent deformation occurred during positioning due to use of the device in difficult lesion morphology.The device was removed from the patient, the case was stopped and postponed for another date.Patient status post-procedure is alive with no injury.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: there was a kink on the hypotube 8.1cm distal to the strain relief.The stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 16th distal stent wraps with struts raised.No deformation was evident to the distal tip.The 0.015 inch mandrel could not load through the guidewire lumen due to hardened blood in the guidewire lumen.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: 7689311
• MDR Text Key: 114548399
• Report Number: 9612164-2018-01745
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2018

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: 06/22/2018
• Device Catalogue Number: RONYX25022X
• Device Lot Number: 0008107315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/16/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 09/26/2018
• Supplement Dates FDA Received: 10/03/2018; 10/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2016
• 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: 55 YR
• Patient Weight: 80