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

Catalog Number RONYX50015UX

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

Patient Problem Injury (2348)

Event Date 08/16/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

During a procedure a resolute onyx rx coronary, drug eluting stent was used to treat a moderately tortuous, mildly calcified lesion in the first obtuse marginal artery.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was not pre dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.The left circumflex came off at a 90 degree angle from a short left main.It was reported that while attempting to advance the stent, the proximal stent was moving in and out of the 6f guide catheter and the stent dislodged.The stent was not removed.It was deployed in the proximal left circumflex with a 3.5 x 15 balloon, then post dilated with a 4.0 and 5.0 balloon.The patient is alive with no other injury.

Manufacturer Narrative

Image review: an image shows a dislodged stent on a guidewire.An image shows a balloon is delivered inside the body of the stent.An image shows the balloon is inflated and the stent is deployed.An image shows a contrast shot after the stent has been deployed.An image shows post dilation of the stent performed.An image shows a balloon is delivered distal to the previous deployed stent.An image shows a stent being delivered.An image shows the stent being deployed.An contrast image shows poor flow to the lcx following stent deployment.An image shows predilation to the proximal lad.An image shows a stent delivered to the proximal lad.An image shows a stent deployed in the proximal lad.A contrast image shows the treated lad.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: 8905347
• MDR Text Key: 154691385
• Report Number: 9612164-2019-03457
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557307
• UDI-Public: 00643169557307
• 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: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2021
• Device Catalogue Number: RONYX50015UX
• Device Lot Number: 0009680361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2019
• Date Device Manufactured: 04/04/2019
• 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: 63 YR
• Patient Weight: 156