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

Catalog Number RONYX27512X

Device Problems Contamination /Decontamination Problem (2895); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

An attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a lesion.There were no abnormalities in relation to the anatomy.There was no damage noted to the packaging.There were no issues noted when removing the device from the hoop/tray.The device did not pass through a previously-deployed stent.It was reported that the physician encountered resistance while attempting to position the stent at the lesion site, the physician removed the device from the system and noted that the stent was deformed in vivo.The procedure was not completed.The patient is reported to be alive no injury.

Manufacturer Narrative

Product analysis summary: the stent was positioned between the markerbands but not meeting specifications due to deformation at the proximal end.Deformation was evident to the 10th, 11th and 12th distal stent wraps with struts raised and overlapping.There was a gel like substance underneath the deformed stent struts.Deformation was evident to the distal tip.The inner lumen patency was verified with a mandrel.No other damage evident to the remainder of the device.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: 7946167
• MDR Text Key: 123382037
• Report Number: 9612164-2018-02668
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2019
• Device Catalogue Number: RONYX27512X
• Device Lot Number: 0008575544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2017
• 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
• Patient Age: 56 YR