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

Model Number RONYX22530UX

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problems Death (1802); Myocardial Infarction (1969); Perforation (2001); Insufficient Information (4580)

Event Date 08/04/2020

Event Type  Death  

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 lesion.There was no issue removing the device from the hoop.The device was inspected with no issues noted.Negative prep was performed with no issues.Resistance was encountered and excessive force was used.It was reported that stent deformation in vivo occurred during positioning.It was stated that a small perforation of the coronary artery occurred.The patient was reported to have deceased.

Manufacturer Narrative

It was reported that the balloon of the ronyx22530ux (lot 0009873532) burst if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: during a selective coronary arteriography procedure.A mildly tortuous, mildly calcified lesion in the mid-distal circumflex via the right femoral approach.The lesion was pre-dilated.It was stated, that the device lodged and a small perforation of the coronary artery occurred.Another stent was deployed to block the perforation.It was stated, that imaging suggested that this intervention was successful.It was indicated, that the ronyx stent had been fully removed at that time.The patient was then moved to icu and coded.It was later stated, that pericardiocentesis and defibrillation were performed on the patient.The vessel in which, the onyx device was deployed was noted to be patent.It was noted, that the device was not inspected on sequential use.The patient was on dapt at the time of the event.It was assessed, that the resolute onyx device partly caused the death event, but was not the only cause attributed to the death.There was no evidence of restenosis or thrombus.It is thought, that the cause of death was mi.It was later stated, that two stents were deployed in the proximal lad and were crossed over with the diagonal branch.It was noted, that the balloon could be placed at this position, but could not with other stent, due to tortuousity of the diagonal branch.The diagonal was able to be dilated satisfactorily with the balloon.Then an attempt was made to deploy a stent in the circ and distal circ artery.Which, was exhibiting 99% occlusion.There was difficulty noted, in getting stent to desired location.An attempt was made to deploy this stent, but it was reported, that the balloon burst.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.

Manufacturer Narrative

Additional information: it was indicated that the stent dislodged.It was later indicated that this balloon burst was related to another, non-medtronic poba device.It was later stated that the patient was ill and that the death was not a fault of medtronic product, instead it was related to the degree of calcification and nature of the anatomy.Initial reporter details updated device evaluation summary: the stent was not present on the balloon and did not return for analysis.The balloon folds were expanded.Crimp impressions were vi sible on the exposed balloon surface.The distal shaft and core wire were kinked.The inner lumen could not be verified with a 0.015 inch mandrel most likely due to hardened blood in the guidewire lumen.The balloon was inflated to nominal pressure of 12atm with no issues noted.No other damage was noted 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.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.

Manufacturer Narrative

Additional information: review of the procedural images provided confirm the presence of a stenotic lesions in the left anterior descending (lad) artery and in the circumflex (lcx) artery.Tortuous morphology of the vessel as well as calcified fibrotic morphology of the lesions was confirmed from the images provided.It was observed that two stents were deployed in the distal and in the proximal segment of the lad, and complete perfusion post deployment was confirmed.Deployment of the two stents in the distal and proximal lcx was also confirmed.Difficulties in getting stent to desired location with disproportional inflation of the balloon was visible, and the stent deformation was confirmed from the images provided.Perforation of the coronary artery is suspected as extravasation of the contrast was observed in the images provided.In the incoming document it was reported that the patient was deceased.However, cause of death cannot be confirmed from the provided images.Patient date of birth provided 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.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: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10541086
• MDR Text Key: 207156328
• Report Number: 9612164-2020-03480
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556751
• UDI-Public: 00643169556751
• Combination Product (y/n): N
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2021
• Device Model Number: RONYX22530UX
• Device Catalogue Number: RONYX22530UX
• Device Lot Number: 0009873532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Date Manufacturer Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 120