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

Catalog Number RONYX25026JX

Device Problems Device Contamination with Chemical or Other Material (2944); Material Distortion (2977)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2017

Event Type  malfunction  

Manufacturer Narrative

Three photographs were provided by the account.Photographs 1 and 2 capture the resolute onyx delivery system, with damage evident to the guidewire entry port.The reported foreign material cannot be confirmed by the photographs.Photograph 3 captures the device information.The size of the ronyx device and lot#0008618199 matches that reported.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician intended to use a resolute onyx stent to treat a lesion.There was no issues noted when removing the device from the hoop/tray.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was not pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.Post dilation was not performed.After the stent was implanted, and the delivery system was withdrawn, the physician noted black dust-like material/black fibrous material was discharged out of the non mdt y connector port.The account confirmed that the wire-exit port was damaged.This occurred before an ivus catheter was about to be inserted.A non mdt catheter and a non mdt guidewire were used in the procedure.The physician noted that among the devices used, black material was only seen on the onyx¿s shaft.There is no injury reported.The foreign material was collected, and it has been under investigation at the pathology department of the hospital.The physician has not concluded that the foreign material was attributed to the resolute onyx.Rather, he had no idea where the foreign material came from, so requested medtronic to perform an investigation so that it may provide a clue to the cause.Foreign material was unconfirmed and no sample of foreign material is available.Delivery system returning.

Manufacturer Narrative

Additional information: no sample of foreign material is available evaluation summary: stent was not returned with the delivery system for analysis.Crimp impressions were visible on the exposed balloon surface.Upon returned crystallisation was visible throughout the balloon and this was dispersed.Visual evaluation was performed, and no foreign material discovered.A 0.014 inch guidewire was loaded through the distal tip and out the gw entry port, no foreign material was visible or had exited the delivery system.However, deformation at the distal cone of the balloon was visible.The balloon failed negative prep.On pressurisation, a longitudinal tear was observed on the balloon distal cone.The balloon failed to maintain pressure.The balloon material was jagged and uneven at the deformation site.Tearing was visible at the gw entry port, though no material had been missing.Also, kinking was evident along the transition shaft, at the gw entry port, during visual inspection.Slight deformation was evident to the distal tip.The inner lumen patency was verified.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: 6833449
• MDR Text Key: 84101376
• Report Number: 9612164-2017-01198
• 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
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2019
• Device Catalogue Number: RONYX25026JX
• Device Lot Number: 0008618199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/31/2017
• Supplement Dates Manufacturer Received: 11/15/2017
• Supplement Dates FDA Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2017
• 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