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

Model Number RONYX25012UX

Device Problems Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)

Patient Problems Thrombus (2101); Injury (2348)

Event Date 02/06/2020

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 85% stenosis in the mid circumflex (cx) artery.There was no damage noted to the packaging or any issues noted when removing the device from the hoop.The device was inspected with no issues noted.Negative prep was performed with no issues.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 delivery to/at lesion.Stent was eventually expanded into place with a smaller balloon.It was stated that the patient came back next day with stent thrombosis.It was also mentioned that the stent could be undersized.The patient was reported to be alive with no further injury.

Manufacturer Narrative

Stent was eventually expanded into place with a 1.5mm balloon.The patient was on dapt at the time of the event.The thrombus was treated with medication.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Cine image review: an angiographic photo provided confirms a stent thrombosis in the lcx.There are no images provided of the reported stent dislodgement.It is not possible to determine from the images if the stent was undersized as reported from the account.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: 9693160
• MDR Text Key: 179109230
• Report Number: 9612164-2020-00666
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556799
• UDI-Public: 00643169556799
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2021
• Device Model Number: RONYX25012UX
• Device Catalogue Number: RONYX25012UX
• Device Lot Number: 0009945934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2020
• Date Device Manufactured: 09/30/2019
• 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: 75 YR
• Patient Weight: 105