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

Catalog Number RONYX30022UX

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

A resolute onyx rx drug eluting stent was used to treat mildly calcified and tortuous proximal lad lesion exhibiting 60% stenosis.No damage noted to device packaging and no issues removing the device from the hoop/tray.The device was inspected and negative prep performed with no issues noted.The lesion was pre-dilated.The device did not pass through a previously deployed stent.No resistance was encountered while advancing the device and no excessive force used.It was reported that there was a loop in the distal end of the non medtronic wire.The wire was pulled hard and part of the wire broke off, and got caught in the lad/diag.When snaring the broken wire, the proximal of deployed resolute onyx stent got snared, and was pulled out of patient.The proximal vessel was then re-stented.No patient injury reported.The patient is reported to be fine.

Manufacturer Narrative

Image review: the returned procedural images capture the patient lesion condition as reported by the account.The pre-dilation of the target lesion is captured in the images.An unknown stent is delivered and implanted in the lad.Post dilation of the implanted stent is also captured.A second stent is successfully delivered and implanted to a diagonal branch of the lad.The complaint device is then delivered and implanted proximal to the previously implanted stents.Attempts to remove the non-medtronic guidewire are captured, however resistance is encountered due to interaction between the guidewire and complaint resolute onyx device.A detached distal portion of the guidewire is visible in the images, the guidewire is caught in the complaint device.Attempts to remove the detached guidewire results in the movement of the complaint device from the patient.A lesion is then stented with an unknown stent in the original location of the complaint stent.Improved flow is visible post procedure.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 7372950
• MDR Text Key: 103538010
• Report Number: 9612164-2018-00576
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557000
• UDI-Public: 00643169557000
• 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
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: RONYX30022UX
• Device Lot Number: 0008778296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 08/31/2017
• 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