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

Catalog Number RONYX40012JX

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/23/2021

Event Type  Injury  

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 calcified and moderately tortuous lesion in the ostium rca with 90% stenosis.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The device did not pass through a previously deployed stent.Resistance was encountered and excessive force was used.It was reported stent dislodgement occurred during delivery to the lesion.A femoral approach was selected for the patient with significantly meandering abdominal aorta.A 100 cm guiding catheter could not reach the coronary arteries, therefore a non medtronic guide extension catheter was used to engage right coronary artery.The lesion was predilated with a non medtronic balloon and the lesion was measured by intravascular ultrasound (ivus).Since there was residual stenosis, preparation was performed again with a larger non medtronic balloon.Ivus was attempted for the second time but was unsuccessful.The resolute onyx was selected for implantation, during advancement the stent was caught near the tip of the non medtronic gec and fell off.It was slowly retrieved by the onyx delivery system.The delivery system was removed and the stent remained in the non medtronic gec.After that, a non-medtronic balloon was used to pass through the stent, slightly inflated at the distal part and was pulled back.As strong resistance occurred on the way and the balloon broke, the entire gec was removed from the body.No patient injury was reported.

Manufacturer Narrative

Additional information: annex d, annex g codes added 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: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11731616
• MDR Text Key: 247488530
• Report Number: 9612164-2021-01669
• 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: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2022
• Device Catalogue Number: RONYX40012JX
• Device Lot Number: 0010278102
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 04/27/2021
• Supplement Dates Manufacturer Received: 06/16/2021
• Supplement Dates FDA Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention