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

Catalog Number RONYX30026X

Device Problems Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intimal Dissection (1333)

Event Date 07/18/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The index procedure was prompted by unstable angina.During the index procedure, two resolute onyx des were implanted in the lad.It was reported that a grade b dissection occurred in the lad during the procedure.The patient recovered.The investigator assessed the event as not related to the anti-platelet medication or to the device.The sponsor assessed the event as not related to the anti-platelet medication and possibly related to the index device.

Manufacturer Narrative

Image analysis summary: a short video clip was provided for analysis.The video shows contrast administered to the rca.Lesions are visible in the rca.There were no images suggesting stent under expansion.There were no images showing the reported dissection.There were no images of the reported lesion returned.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The prox lad had 90% stenosis.Calcification was mild to none.The mid lad had 90% stenosis.Calcification was mild to none.The 3.0x26mm resolute onyx stent was implanted at 18 atms in the proximal lad.The stent was not post-dilated.There was a 10% residual stenosis.Stent underexpansion was seen during oct imaging.The patient was discharged with no complication and no symptoms.No intervention was planned for the underexpanded stent.A medtronic device was not believed to have caused the previously reported dissection.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: 8721352
• MDR Text Key: 148761158
• Report Number: 9612164-2019-02459
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2020
• Device Catalogue Number: RONYX30026X
• Device Lot Number: 0009048189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2019
• Date Device Manufactured: 03/26/2018
• 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): Hospitalization
• Patient Age: 75 YR
• Patient Weight: 51