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

Model Number RONYX35038UX

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 12/13/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An attempt was made to use a resolute onyx coronary drug eluting stent to treat a mildly tortuous, severely calcified lesion in the proximal left main coronary artery.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was used when advancing the device.It was reported that the stent dislodged occurred during delivery.The dislodged stent was removed with a snare.No further injury was reported.

Manufacturer Narrative

Additional information: the proximal left main coronary artery had 70% stenosis.There was 70% stenosis in the lad and 90% stenosis in the circumflex artery with heavy calcification noted.The lesion was pre-dilated and shockwave lithotripsy was performed.Patient age, weight gender.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 stent was not present on the balloon and did not return for analysis.A kink was evident on the hypotube.The inner member was b unched at the proximal markerband.Crimp impressions were visible on the exposed balloon surface.The balloon folds remained intact.No deformation evident to the distal tip.The inner lumen patency was verified.No other damage evident to the remainder of the de vice.Section g: all manufacturers contact updated.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: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13058931
• MDR Text Key: 282604760
• Report Number: 9612164-2021-04956
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557130
• UDI-Public: 00643169557130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RONYX35038UX
• Device Catalogue Number: RONYX35038UX
• Device Lot Number: 0010734694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 114 KG