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

Catalog Number RONYX20012X

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2017

Event Type  malfunction  

Event Description

The physician was attempting to use a resolute onyx rx drug eluting stent to treat a moderately calcified and moderately tortuous mid lad lesion.No damage noted to device packaging and no issues were noted when removing the devices from the hoop/tray.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated.During the procedure, the device passed through a previously deployed stent in the proximal section of the vessel without issue.It was reported that the stent failed to cross through a small lesion proximal to the previously deployed stent.Several attempts were made unsuccessfully.Excessive force was not used.The physician removed the device and upon inspection it was noted that a very fine fragment or hair was on the distal part of the stent.The physician assumed that it prevented the stent tracking.The guidewire used in the procedure had been successfully used for lesion prep and delivery of a previous stent without issue.No issues were noted loading the device onto the guidewire, and it was used successfully with other devices after the difficulties with the resolute onyx occurred.Another stent was used and deployed to complete the procedure.No patient injury reported.Please note that this device, resolute onyx is not marketed in the united states; however, it is similar to the united states marketed product resolute integrity.This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.

Manufacturer Narrative

Product analysis: the stent delivery system was returned for evaluation.A thin blue fibre was visible on the 3rd distal stent wrap under two stent struts.The stent was positioned on the balloon between the marker bands as per specifications.There was no deformation to the stent wraps.There was deformation to the distal tip.There was a kink on the distal shaft 4.4cm and 4.9cm distal to the guidewire entry port.The balloon had to be inflated in order to remove the fibre.The fibre was analysed by fourier transform infrared spectroscopy (ftir) in order to determine the most likely origin of the material.The fibre was compared against a sample of the hospital drapes used during the procedure.The results of the ftir analysis confirmed that the fibre on the stent was a 98.88% match to the sample of the hospital drapes.Results of the analysis therefore did not identify a manufacturing or device related origin for the foreign material.(b)(4).

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: 6367600
• MDR Text Key: 68602763
• Report Number: 9612164-2017-00223
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P110013
• 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: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2017
• Device Catalogue Number: RONYX20012X
• Device Lot Number: 0007865488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2015
• 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