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

Catalog Number RONYX35012X

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2020

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 one resolute onyx rx coronary drug eluting stent to treat a moderately tortuous, moderately calcified lesion located in the right coronary artery (rca).There was no damage noted to the packaging.There was no issues noted when removing the device from the hoop.Negative prep was not performed.The lesion was pre-dilated.The device did pass through a previously deployed stent.It was reported that the stent failed to advance to the lesion so the device was removed from the patient.It was stated that the stent was found to be fractured at the distal struts.An image provided shows a stent strut lifted.The procedure was completed using another resolute onyx stent of the same size.The event did not lead to or extend patient hospitalisation.The patient was reported to be alive with no injury.

Manufacturer Narrative

Additional information: still image review: two images were provided for review.The first image was of the shelf carton of the device, the lot number and device details match what was reported in gch.The second image provided was of the distal section of the device, deformation was evident to the distal section of the stent.There was no image showing a fracture of the stent.Device evaluation summary: device returned for evaluation.The stent had moved distally on the balloon and was not positioned on the balloon between the markerbands as per specifications.Crimp impressions were visible on the exposed balloon surface.Deformation was evident to the distal and proximal stent wraps with struts raised.Deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.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.

Manufacturer Narrative

Additional information: the lesion was located in the middle and severe distal third of the right coronary artery with timi flow 111.Pre-dilated with a 2.5 x 10mm long balloon at 14 atm.The lesion was transversed with a 0.014" floppy rope due to great tortusity and calcification, it was necessary to progress a non-me dtronic guide extension catheter.It was stated that attempts were made to progress the device but it was not possible to progress due to the stent strut fracture.Completed using another two resolute onyx stents of the same size (3.5 x 12mm) and a third resolute onyx (3.5 x 18 mm).An intrastent balloon (3.5 x 8mm) was used for post-dilatation at 20 atm.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: 10288752
• MDR Text Key: 199294681
• Report Number: 9612164-2020-02646
• Device Sequence Number: 1
• Product Code: NIQ
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2020
• Device Catalogue Number: RONYX35012X
• Device Lot Number: 0009340208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1