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

Model Number RONYX25038UX

Device Problems Fracture (1260); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a procedure an attempt was made to use two resolute onyx rx coronary drug eluting stents to treat a severely tortuous, severely calcified lesion exhibiting 90% stenosis located in the mid right coronary artery (rca).The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that stent deformation occurred in vivo during advancement / positioning.It was stated that the two resolute onyx stents failed to cross the lesion.The stents were removed from the patient and inspected.Upon inspection the stent struts in the mid portion were noted to be raised and fractured.The patient was reported to be alive with no injury.

Manufacturer Narrative

Product analysis:the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the mid stent wrap with struts raised.No deformation was evident to the distal tip.The inner lumen patency could not be verified with a 0.015 inch mandrel most likely due to hardened blood in the guidewire lumen.There was no other damage evident to the remainder of the device.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10177887
• MDR Text Key: 195920924
• Report Number: 9612164-2020-02276
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556867
• UDI-Public: 00643169556867
• Combination Product (y/n): N
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

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: 07/09/2021
• Device Model Number: RONYX25038UX
• Device Catalogue Number: RONYX25038UX
• Device Lot Number: 0009822749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 07/30/2020
• Supplement Dates FDA Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 130