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

Model Number	RONYX30012UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Occlusion (1984); Injury (2348)
Date of Event	03/19/2020
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 rx coronary drug eluting stent to treat a moderately tortuous, severely calcified lesion located in the proximal circumflex (cx) artery.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 used during delivery.It was reported that stent dislodgement occurred during removal following failed delivery.It was stated that a direct stent was attempted first but was unsuccessful so a balloon was used to pre-dilate the lesion.The stent was attempted to be used for the second time.It was stated that calcium was felt grinding on the stent.The stent failed to cross the lesion and during removal it possibly caught on some calcium and the stent started coming off the balloon.The balloon was put back through the stent and it was deployed a little more proximal in the cx artery to where it was intended to be deployed and into distal left main and jailed the left anterior descending artery.The patient was reported to be alive with no injury.
Additional Manufacturer Narrative
Additional information: it was later indicated that the deployment of the stent in the proximal cx artery jailed the lad and caused the lad to be completely occluded.The lad was opened during another procedure on (b)(6) 2020.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Incorrect aware date was submitted in the 3rd mdr in error the correct aware date should be the 26th of may.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: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9864632
• Report Number: 9612164-2020-01286
• Device Sequence Number: 13570283
• Product Code: NIQ
• UDI-Device Identifier: 00643169556973
• UDI-Public: 00643169556973
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/29/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2020
• Device Model Number: RONYX30012UX
• Device Catalogue Number: RONYX30012UX
• Device Lot Number: 0009486998
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 04/06/2020; 04/06/2020; 05/26/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 04/21/2020; 05/27/2020; 05/29/2020
• 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