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

Catalog Number RONYX22522UX

Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem Injury (2348)

Event Date 12/19/2019

Event Type  Injury  

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 a resolute onyx rx coronary drug eluting stent.It was reported that while attempting to pass a previously implanted stent in the circumflex that the device became caught and dislodged.The dislodged stent required surgery in order to remove from the patient.

Manufacturer Narrative

Aware date of initial regulatory report 9612164-2020-00390 corrected to 19-dec-2019.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The lesion in the mid left main was non-tortuous and non calcified.No damage was noted to packaging.No issues were noted when removing the device from the hoop.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did not pass through the previously-deployed stent.The previously deployed stent was described as chronic.Resistance was encountered when advancing the device.Excessive force was not used during delivery.The stent dislodged into the left main.The patient also required open heart surgery.Patient health status is alive with no injury.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image analysis summary: the image captures a dislodged stent and two previously deployed stents.The proximal end of the dislodged stent that is located in the left main appears to be damaged.Based on its location on the vessel, its proximity to the tip of the guide catheter and the damage to the proximal end of the stent, it appears most likely that the stent may have interacted with the tip of the guide catheter as the undeployed stent and delivery system were being pulled proximally out of the vessel after resistance was experienced during attempted delivery.The reason for the attempted delivery is unclear but the possibility exists that the device was unable to pass through the previously deployed stent.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction: aware date of 9612164-2020-00390 follow up 001 corrected to 27-jan-2020.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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9622161
• MDR Text Key: 176060516
• Report Number: 9612164-2020-00390
• Device Sequence Number: 1
• Product Code: NIQ
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/31/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2021
• Device Catalogue Number: RONYX22522UX
• Device Lot Number: 0009806040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2019
• Initial Date FDA Received: 01/23/2020
• Supplement Dates Manufacturer Received: 01/29/2020; 01/27/2020; 12/19/2019; 03/27/2020
• Supplement Dates FDA Received: 02/18/2020; 02/24/2020; 03/02/2020; 03/31/2020
• Date Device Manufactured: 06/29/2019
• 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: 64 YR