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

Model Number RONYX30018UX

Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976)

Patient Problems Intimal Dissection (1333); Occlusion (1984); Patient Problem/Medical Problem (2688)

Event Date 06/26/2017

Event Type  Injury  

Manufacturer Narrative

Dob, year only valid.

Event Description

The physician was attempting to use a 3.0x18mm resolute onyx drug eluting stent during a procedure to treat a lesion in a moderately tortuous rca.The lesion was mildly calcified, with 70% stenosis.The lesion was pre-dilated.No damage was noted to packaging.No issues were noted when removing the device from the hoop.The device was inspected with no issue.Negative prep was performed with no issue.The device did not pass through a previously-deployed stent.There was no resistance encountered and excessive force was not used.It is reported that stent deformation occurred in vivo post deployment.A cougar wire and nc balloon were used during post-dilatation.When attempting to post dilate, the nc balloon was having trouble getting into the stent.During that, the operator lost wire position.He re-wired the vessel and attempted to pass the balloon again but noticed the stent moving when he moved the wire.It is reported that the stent appeared to be properly apposed to the vessel wall, however it's possible a strut was not and it seemed like the wire went behind a strut on the re-wire attempt, and that was what caused the stent to move/ deform.He removed the wire with difficulty and the stent deformed a little in the prox/mid section.He attempted to re-wire, but the wire kept prolapsing at the prox portion of the stent (appeared to be deflecting).During this time the wire appeared to be "hugging" the top of the vessel, which the operator believed may have been because of the bend.After trying to wire for a few minutes he flouro'd and saw that there was a dissection proximal to the stent.He then put another resolute onyx (3.5x12mm) proximal to the deployed stent to cover the dissection.The wire was still not through the previously deployed stent.On the next picture the vessel was completely occluded after the 3.5x12mm stent (the proximal one).A balloon pump was placed and a temporary pacing wire.The patient was then transferred for emergency bypass.Surgery was successful and patient is recovering.Patient status is described as alive with injury.It is reported that the physician believes the guidewire may have caused the dissection but it is unknown for sure.The physician commented that they thought it was from the guide as it was very deep seated at times when trying to rewire, and that the wire may have gone sub intimal when trying to get it through the distal stent.The physician also commented that the dissection was not caused directly by the onyx stent, as it happened after trying to get a wire through after it was deployed.

Manufacturer Narrative

Additional information: a zuma (ar10) guide catheter was used during re-wiring.The physician commented that the zuma guide catheter may have caused the dissection but it is unknown for sure.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: 6739456
• MDR Text Key: 80867287
• Report Number: 9612164-2017-00932
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556997
• UDI-Public: 00643169556997
• 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
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2019
• Device Model Number: RONYX30018UX
• Device Catalogue Number: RONYX30018UX
• Device Lot Number: 0008527232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2017
• Date Device Manufactured: 03/10/2017
• 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
• Patient Age: 68 YR