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

Catalog Number RONYX35018JX

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A resolute onyx drug eluting stent was been used to treat a lesion in the right coronary artery (rca).The lesion exhibited mild tortuosity, mild calcification and 90% stenosis.The device was inspected and prepped prior to use with no issues noted.The lesion was pre-dilated twice with a euphora balloon, 25% stenosis remained.When the resolute onyx was delivered to the lesion strong resistance was encountered within the non- medtronic 5f guiding catheter.It was reported that excessive force was used.The resolute onyx was implanted, however it was unknown if the shaft was damaged.When the y-connector was opened at the end of the procedure, small foreign material (black gruel-like) appeared in the returned blood.The physician commented that it was not a part of the system balloon of the resolute onyx.No damage was noted to the guiding catheter, damage of lumen was unknown.The patient was reported to be alive with no injury.

Manufacturer Narrative

A blood-soaked swab was returned to the lab for analysis.Particulate was found on the blood-soaked swab.The device was discarded by the account.Scanning electron microscopy and x-ray microanalysis was carried out on the particulate contained in the swab and a control tubing sample.It was found that there was a correlation between the particulates and the control tubing sent for testing.It was also found that the morphology of the particulates was swarf-like and curled up.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: 8183813
• MDR Text Key: 131006028
• Report Number: 9612164-2018-03735
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/17/2019

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: 07/18/2019
• Device Catalogue Number: RONYX35018JX
• Device Lot Number: 0008719605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2019
• Date Device Manufactured: 07/18/2017
• 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