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

Catalog Number RONYX20012UX

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 07/01/2019

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 2.25mm resolute onyx rx coronary drug eluting stent to treat a lesion.The stent failed to cross the lesion.An attempt was then made to use a 2.00x12mm resolute onyx stent to treat a severely tortuous, mildly calcified lesion exhibiting 95% stenosis in the ostium in the left anterior descending (lad) artery.The device was inspected with no issues.Negative prep was performed without issue.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.It was reported that stent dislodgement occurred during removal following a failed delivery.The stent had to be deployed proximal to the target location.The stent was not deployed using the stent delivery system.The stent was re-crossed by other smaller balloons and gradually getting bigger ending with a 3.0 balloon.The lad was the intended lesion.Patient is alive but remains in hospital.The patient is alive and is awaiting bypass surgery because of the failure to fix the lad.

• 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: 8826394
• MDR Text Key: 152190702
• Report Number: 9612164-2019-03047
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556638
• UDI-Public: 00643169556638
• 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
• Report Date: 07/25/2019

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: 04/20/2020
• Device Catalogue Number: RONYX20012UX
• Device Lot Number: 0009092419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/25/2019
• Date Device Manufactured: 04/21/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 75