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

Model Number RONYX30022X

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that an attempt was made to use a resolute onyx drug eluting stent to treat a lesion in the proximal lad with moderate tortuosity and calcification.No abnormalities were noted in the patient¿s anatomy.The device was removed from packaging with no issues noted.The device was inspected with no issues noted.The lesion was predilated.Resistance was not noted, and excessive force was not used.It was reported that during stent expansion, the stent did not appear to be fully crimped on the balloon and was shifting during the first few seconds of inflation.Subsequently, the stent migrated after deployment into the ostial left main.It was reported that the lesion was partially covered.The stent was post dilated to ensure better opposition within the arterial wall.The inflation pressure was normal and no incidences of under expansion reported.No patient complications were reported for this event.

Manufacturer Narrative

Additional information received reported that the lesion was at the proximal lad, but during stent deployment at the lesion, the physician noted that 2 seconds after inflation, the stent had shifted out away from the balloon, into the left main (lm) artery.The stent had originally reached the target lesion, but during inflation the stent had seemingly detached from the balloon 2 seconds after inflation, and shifted into the lm, thus after inflation partially covering the lesion.There was no issue with deliverability, the onyx was able to cross the anatomy.After the stent had migrated, the stent was just barely able to cover the lesion.Subsequently the stent was post dilated to ensure better opposition within the arterial wall.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.

Manufacturer Narrative

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

Manufacturer Narrative

An image shows a lesion in the proximal lad as reported by the account.A balloon is positioned at the lesion.A stent is delivered to the lesion.The stent is deployed at the lesion.A final angiogram shows patency restored to the vessel as shown by the flow of contrast.No images show that the stent was not properly crimped.No images show the reported detachment.Stent migration could not be confirmed from the images due to the quality of the images.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: 7684679
• MDR Text Key: 114177583
• Report Number: 9612164-2018-01713
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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,Followup,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2019
• Device Model Number: RONYX30022X
• Device Catalogue Number: RONYX30022X
• Device Lot Number: 0008871769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/09/2017
• 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