MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE ONYX RX

Catalog Number RONYX20022JX

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 10/17/2019

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 to treat a moderately tortuous, severely calcified lesion exhibiting 90% stenosis located in the circumflex (cx) artery.The device was inspected and negative prep performed without issues.The device was not kinked and re-straightened during the procedure.The lesion was pre-dilated using a non-medtronic device at 12atm for 15 seconds.After pre-dilation it was judged that a stent was able to be implanted.The device passed through a previously deployed non medtronic stent which was implanted two weeks previous.Resistance was not encountered when advancing the device.It was reported that the resolute onyx stent became caught in the previously implanted stent, and upon attempted removal stent dislodgement and detachment occurred.There were removal difficulties noted.The dislodged/detached portion of the device was removed successfully using a snare.The patient was reported to be alive with no further injury.

Manufacturer Narrative

It was reported that a full detachment of the device occurred.Previously reported implant date is not applicable as the stent was not implanted.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• 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: 9237283
• MDR Text Key: 164270724
• Report Number: 9612164-2019-04505
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

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: 07/10/2021
• Device Catalogue Number: RONYX20022JX
• Device Lot Number: 0009821032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 10/29/2019
• Supplement Dates FDA Received: 11/12/2019
• Date Device Manufactured: 07/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR