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

Catalog Number RONYX25022X

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2021

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 lesion exhibiting 45% stenosis located in the distal left anterior descending (lad) artery.The device was inspected with no issues noted.Negative prep was not performed.It was reported that the device detached cracked or fractured at the catheter during delivery through the vessel.It was also stated that a stent fracture occurred.The detached portion does not remain in the patient and was removed during the procedure.No medical or surgical intervention was needed to prevent a permanent impairment of a function.The patient was reported to be alive with no injury.

Manufacturer Narrative

Device evaluation summary: device returned for evaluation.Kinks were noted on the hypotube and distal shaft.There was a detachment on the hypotube 59cm distal to the strain relief.The hypotube material was oval and jagged on both sides of the detachment site.The stent was positioned on the balloon between the marker bands as per specifications.No deformation was noted to the stent.No deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.No other damage evident to the remainder of the device.Additional information: there was no damage to the packaging.The lesion was not pre-dilated.Resistance was noted during delivery of the device.Excessive force was not used.The device was not bent and straightened during use.The fracture occurred when positioning the device in the lesion.The fracture occurred at the distal axis of the device.The fractured portion was removed from the patient using a multi-snare catheter.The procedure was completed with two other resolute stents.The patient was reported to be alive with no further injury.Patient weight provided adverse event (&) product problem selected intervention required ticked 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 ; EI
• MDR Report Key: 11312601
• MDR Text Key: 231318822
• Report Number: 9612164-2021-00605
• 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
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2022
• Device Catalogue Number: RONYX25022X
• Device Lot Number: 0010357210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Date Manufacturer Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 69