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

Catalog Number RONYX25026X

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problems Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Date 06/16/2023

Event Type  Injury  

Manufacturer Narrative

Still image review: three photos of the device and packaging were received.The device images included a photo of the device coiled on the bench and of the distal end of the stent delivery system.The balloon is not expanded but the stent is no longer on the balloon.The third photo is of the labelled device shelf carton with product identification 2.5 x 26mm resolute onyx device with lot # 0011560478.Procedural image review: four still fluoroscopic images were provided for review.The images were provided in a very small font making it difficult to identify details.Image 1 appears to show multiple lesions in the left coronary system, the target lad lesion can be seen in the images.Image 2 shows a different view of the proximal to mid lad lesion.Image 4 appears to show the dislodged stent in the proximal to mid-lad.The dislodged stent appears to have been pulled back towards the ostium of the left coronary system.No images were provided showing the snaring of the stent or the crushing of the stent wire wraps in the left main.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.

Event Description

During a pci (percutaneous coronary intervention) an attempt was made to use one resolute onyx coronary drug-eluting stent to treat a calcified lesion with 85% stenosis in the proximal/mid left anterior descending (lad) artery.There were issues noted when removing the device from the hoop/tray.The device was not inspected.The lesion was predilated with a 2.5x15mm balloon.It was reported that the stent failed to be delivered.A 6f ebu 3.5 guide catheter and a 0.014 non-medtronic guidewire had initially crossed the lesion.Following pre-dilation the stent failed to cross the lesion.The lesion was treated to further pre-dilation with a 2.5x12mm non-medtronic balloon using the scoring technique and a non-medtronic buddy wire was used to attempt to place the stent.A non-medtronic guide extension catheter was used to insert a balloon to assist in positioning the stent however, the stent was stuck at the proximal lad.It was reported that stent dislodgement occurred using cine to visualized the dislodged portion in the left main (lm) coronary artery.A non-medtronic 7fjl3.5 guide catheter was inserted via the lfa (left femoral artery) and a non-medtronic snare was inserted to retrieve the stent.A verification check was conducted by ivus (intravascular ultrasound) which showed a few residual stent struts attached to the distal lm wall.A 3.5x8mm non-medtronic device was used to crush the stent struts to the wall of the lm.A final verification ivus check showed good stent strut apposition, no dissection of the lad and lm, and final timi 3.The patient was placed on dapt for 12 months.No further patient injury was reported.

Manufacturer Narrative

Additional information: there were no issues noted when removing the device from the hoop/tray.The device was inspected before use.Negative prep was performed.A 2.5x15mm non-medtronic balloon was used to pre-dilate the lesion.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device and excessive force was used due the presence of a lot of calcium.When the device was advanced the delivery of the device failed, and the stent became stuck at the proximal lad.It was later confirmed that the non-medtronic guide extension catheter was used to attempt to pull the stent back into the guide extension catheter, and not to insert a balloon to attempt to position the stent.The stent dislodged when attempting to pull it back into the guide extension catheter.It was later confirmed that the stent was successfully removed, and no part of the stent detached/broke and no fragments were left in the lm.A non-mdt balloon was used to treat the lad and lm lesions.The final result was successful.Correction: phone number.Annex a code.Procedural images: in image 3 there appears to be a dislodged stent in the proximal to mid lad.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: 17258706
• MDR Text Key: 318483834
• Report Number: 9612164-2023-02875
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RONYX25026X
• Device Lot Number: 0011560478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2023
• Date Device Manufactured: 12/19/2022
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 75 KG