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

Model Number RONYX30022X

Device Problems Deflation Problem (1149); Difficult to Insert (1316); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A resolute onyx rx coronary, drug eluting stent was used during angioplasty to treat a patient with coronary heart disease with mode rately tortuosity, in the distal circumflex (cx) artery, there was no issue noted when removing the device from the hoop.The device was inspected with no issues.Negative prep was not performed.The device did not pass through a previously deployed stent.Resistance was encountered.Excessive force was not used during delivery.The balloon was inflated as per the instructions for use with the product.It was reported that deflation difficulties were encountered and the stent dislodged during removal following a failed delivery.The stent was not removed from the patient and is still in the radial artery as there was no problem with the arterial flow.It was also reported that the stent was removed with a guide and the balloon remains in the radial artery.The procedure was ended with a view to perform reintervention the following day.The patient is alive with no injury.

Manufacturer Narrative

Additional information: there were no issues noted when removing the protective sheath or the packaging stylette.The lesion was pre-dilated.24 atm of pressure was applied during inflation.No difficulties were noted during inflation.The device was not moved or re-positioned in the lesion while inflated.Deflation difficulties were encountered after first inflation the stent was not removed from the patient difficulties were noted when removing the balloon from the patient.It was also indicated that multiple attempts to remove the balloon from the patient using negative pressure were performed but were unsuccessful.It was stated that with continuous traction the balloon was able to be withdrawn with retraction of the stent to the radial artery.When the device was withdrawn it was noted that the balloon remained inflated.Correction: device code - c63228 medtronic is submitting this report to comply with fda reporting regulations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

Product analysis summary: the transition shaft was stretched and kinked.The stent was not present on the balloon and did not return for analysis.Crimp impressions were visible on the exposed balloon surface.The balloon folds were expanded.There was a detachment at the proximal balloon bond.The balloon material had turned inside out and was positioned over the distal tip and off the delivery system.The inner member was necked.The markerbands were not positioned correctly.The exchange joint was severely stretched.It was not possible to verify the inner lumen due to the condition of the returned delivery system.It was not possible to perform deflation testing due to condition of returned delivery system.There was no other damage evident to the remainder of the delivery system.Two angiographic images and one still image were provided for review.The angiographic images confirm the stent had expanded in the vessel and the migration of the dislodged stent to the radial artery.The still image provided is of the still inflated balloon after withdrawal from the patient.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

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
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10342855
• MDR Text Key: 201382710
• Report Number: 9612164-2020-02816
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/17/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2021
• Device Model Number: RONYX30022X
• Device Lot Number: 0010056871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 07/30/2020
• Supplement Dates Manufacturer Received: 08/13/2020; 09/08/2020; 11/13/2020
• Supplement Dates FDA Received: 08/31/2020; 09/29/2020; 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR