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

Catalog Number RONYX25015X

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2017

Event Type  malfunction  

Event Description

The physician intended to use a 2.5x15mm resolute onyx drug eluting stent to treat a non tortuous mildly calcified lesion in the mid lad.No abnormalities were reported in relation to anatomy.A right femoral approach was used.No damage was noted to the packaging and no issues noted when removing the device from the hoop.The device was inspected and negative prep was performed with no issues.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.No resistance was encountered when advancing the device and excessive force was not used during delivery.The lesion was post-dilated.It is reported that the stent moved position after deploying and removal of the delivery system.The stent was deployed at 8atm.A sufficient vacuum was pulled on the delivery system balloon to ensure complete deflation prior to removal.Movement did not occur during post-dilation activities.The lesion was not resistant.Post dilatation was done with an nc euphora 2.5 x 8 mm.The stent did not move to an area of the artery that had a larger id that the lesion site.There was no interaction between the resolute onyx stent and accessory devices post-deployment.The current location of the deployed stent is the mid lad.Patient status is alive with no injury.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: two cine images were provided for review.The first image was labelled ¿before deployment¿.The image captures the patient's lad, the image confirms the reported lesion condition.The image captures a guidewire in the lesion.The 2.50x15mm resolute onyx stent is not visible in the image provided.The second image was labelled ¿after deployment¿.The image captured what appears to be marker band for an unknown device in the lad.The reported stent migration cannot be confirmed by the images provided.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: 7211648
• MDR Text Key: 98193939
• Report Number: 9612164-2018-00127
• 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
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2019
• Device Catalogue Number: RONYX25015X
• Device Lot Number: 0008395187
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2018
• Date Device Manufactured: 01/23/2017
• 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