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

Catalog Number RONYX30026JX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombus (2101); Rupture (2208); Injury (2348)

Event Date 07/11/2019

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 used to treat a mildly tortuous, mildly calcified lesion in the left anterior descending (lad) artery.There was no damaged noted to the packaging.There were no issues removing the device from the hoop.The device was inspected with no issues.Negative prep was performed with no issues noted.Pre dilation was performed for the target lesion.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during the delivery.The device was implanted with no issues and the procedure completed.The following day, the patient suffered sub acute (>24 hours-30 days) stent thrombosis.An emergency poba procedure was performed using a balloon to inflate within the stent to restore blood flow.The procedure was completed.

Manufacturer Narrative

Additional information: it was stated that although the stent was fully expanded there seemed to be a slight plaque leak.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: prior to the procedure, the patient had a slight fever of 37 degrees, and crp was a little high at 8.0.The patient was put on dapt four days prior to the pci procedure.One month after pci was performed, the patient was discharged from the hospital 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: 8841203
• MDR Text Key: 152637054
• Report Number: 9612164-2019-03117
• 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: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2020
• Device Catalogue Number: RONYX30026JX
• Device Lot Number: 0009206929
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2019
• Date Device Manufactured: 06/26/2018
• 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
• Patient Age: 73 YR
• Patient Weight: 50