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

Model Number	RONYX20018UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Insufficient Information (4580)
Date of Event	06/16/2020
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 two resolute onyx rx coronary drug eluting stents to treat a moderately tortuous lesion located in the distal left anterior descending (lad) artery.The devices did pass through a previously deployed stent.Resistance was encountered when advancing the devices.It was reported that stent dislodgement occurred during removal following failed delivery.It was stated that the dislodged stent was removed using a snare.It was stated that two operators (4th year fellows and 2nd day operators), under the supervision of the attending physician, implanted a long non-medtronic stent to the proximal/mid lad overlapping previous implanted stents placed in the same anatomy in a previous procedure.This non-medtronic stent was placed because the patient was suffering from in-stent restenosis.After implantation of this non-medtronic stent, an occlusion occurred in the distal lad.An attempt was then made to implant a resolute onyx 2.0 x 12mm stent into the distal lad to fix the distal occlusion of the lad.After insertion of the stent distal to the non-medtronic stent in the lad, it was decided to pull the stent out and utilize a longer stent, a resolute onyx 2.0.X 18mm stent instead.Upon removal of the undeployed 2.0 x 12mm onyx stent, the onyx 2.0 x 12 stent had caught onto the non-medtronic stent and the onyx stent dislodged from the balloon, however this was not observed at the time.Upon attempting to then implant the onyx 2.0 x 18mm stent, it was noticed that the stent would not pass through the previously deployed non-medtronic stent located in the proximal/mid lad.It was noted that the anatomy of the lad was moderately tortuous as it bent off away from the ramus.After some time of trying to advance the 2.0 x 18mm onyx stent through the non-medtronic stent, it was decided to pull the stent out.It was then noticed that both stents had been dislodged from their respective balloons inside the lad and a snare was then used to snare the two resolute onyx stents out of the patient.After the stents were removed, it was noted that the distal lad occlusion had corrected itself, and was no longer occluded.The patient is doing well and no further injuries were reported.
Additional Manufacturer Narrative
Additional information: lesion with 99% stenosis.There was also timi-3 flow in the vessel.The devices were inspected before use.Negative prep was performed.The lesion was pre-dilated.Excessive force was not used during delivery.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
Product analysis: four cd were returned for analysis, all images received were from procedure(s) carried out in one 7-hour period.Multiple stents were visible with the lumen, the dislodgement of the undeployed stent from the stent delivery system was not captured however the dislodged stent was identified in proximal portion of the deployed stents and was removed with the use of a snare.Product analysis : one dislodged stent was received for analysis.The delivery system was not received for analysis.Deformation was noted to the dislodged stent.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: four cds containing procedural images were returned for analysis.In-stent restenosis was visible in a previously deployed stent.Multiple stents were visible with the vessel, the dislodgement of the undeployed stent from the stent delivery system was not captured however the dislodged stent was identified in proximal portion of the deployed stents and was removed with the use of a snare.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: 10223133
• Report Number: 9612164-2020-02391
• Device Sequence Number: 11549234
• Product Code: NIQ
• UDI-Device Identifier: 00643169556652
• UDI-Public: 00643169556652
• 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
• Device Explanted Year: 2020
• 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,Followup
• Report Date (Section B): 11/30/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/18/2021
• Device Model Number: RONYX20018UX
• Device Catalogue Number: RONYX20018UX
• Device Lot Number: 0009926802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 08/31/2020; 10/22/2020; 11/25/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 09/22/2020; 11/17/2020; 11/30/2020
• 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
• Patient Age: 80 YR
• Patient Weight: 84