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

Model Number	RONYX20012UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Insufficient Information (4580)
Date of Event	07/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure an attempt was made to use one resolute onyx coronary drug eluting stent to treat a mildly tortuous and moderately calcified lesion in the proximal/ mid lad artery with 90% stenosis.There were no issues noted removing the device from the protective hoop.The device was inspected with no issues noted.Negative prep was not performed.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 used during delivery.It was reported that two stents failed to cross the lesion.The resolute onyx was then attempted to cross the lesion, however the stent dislodged on calcification during removal following failed delivery.The stent was not removed and the patient was sent for cabg.The patient is alive with no injury.
Additional Manufacturer Narrative
Additional information: no resistance was experienced when removing the sheath/stylette.It was reported that both a 2.5 x 22 mm resolute onyx stent and a 2.5 x 12 mm resolute onyx stent failed to cross the lesion initially.Attempts were made to try to use a smaller non-medtronic balloon inside the stent to expand and deploy.A second non-medtronic wire was inserted to try and get the balloon along the undeployed stent and crush it against the wall but these were not successful.The dislodged stent was not removed during the cabg procedure.The patient is reported to be stable and was discharged.Implant date added (d6a) annex g code 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.
Additional Manufacturer Narrative
Additional information: procedural images were provided for review.The images show a lesion in the mid - proximal left anterior descending artery.Multiple pre-dilations through the vessel are observed but it appears that concentric expansion can not be achieved suggesting difficult vessel morphology.Use of the telescope device is also observed.The resolute onyx stent is observed within the vessel and subsequent images show the dislodged stent appears to remain in the vessel after guidewire has been removed.No images are provided to show difficulties crossing the lesion or the dislodgement occurring.No images were provided of a 2.5 x 22 mm resolute onyx stent and a 2.5 x 12 mm resolute onyx stent failing to cross the lesion.Annex d codes added correction: annex e code 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
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12292588
• Report Number: 9612164-2021-03042
• Device Sequence Number: 11558678
• Product Code: NIQ
• UDI-Device Identifier: 00643169556638
• UDI-Public: 00643169556638
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2024
• Device Model Number: RONYX20012UX
• Device Catalogue Number: RONYX20012UX
• Device Lot Number: 0010685117
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 08/11/2021; 10/18/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 08/19/2021; 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 73