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

Model Number	RONYX25030UX
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
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 mildly tortuous, mildly calcified lesion exhibiting cto (chronic total occlusion-100%) located in the proximal posterior descending artery (pda).The device was inspected 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 deformation occurred in vivo during positioning / advancement.It was stated that two attempts were made to delivery the stent.It was stated that on the first attempt to deliver the stent, there was no issue with delivery or removal from the vasculature.The stent was advanced to the lesion location of pda and removed from the guide in order to place a non medtronic balloon in the proximal posterolateral branch (plb) to prevent jailing and plaque shift of the plb.The stent was inspected prior to the second attempt to deliver the stent to ensure the stent was still intact.The stent would not advance to the lesion location in the pda on this attempt.The stent detached during advancement through the guide catheter on the second attempt to deliver the stent.It was stated that the wire moved when trying to advance or withdraw the balloon and the stent then became stuck in the guide, but did not exit the tip of the guide.Difficulty removing the device was experienced prior to the stent deployment.No occlusion to the plb occurred.Following several attempts to withdraw the stent from the guide, the stent was removed.It was stated that, approximately half of the stent was partially detached from the delivery system and the other half was still attached to the delivery system.The patient was reported to be alive with no injuries.
Additional Manufacturer Narrative
Product analysis summary: the stent was not positioned on the balloon between the marker bands as per specifications due to deformation of mid to distal stent warps.Deformation was evident to the mid to distal stent wraps with struts stretched.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.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: 9822554
• Report Number: 9612164-2020-01131
• Device Sequence Number: 14220066
• Product Code: NIQ
• UDI-Device Identifier: 00643169556843
• UDI-Public: 00643169556843
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: RONYX25030UX
• Device Catalogue Number: RONYX25030UX
• Device Lot Number: 0009812465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 117