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

Catalog Number RONYX25018UX

Device Problems Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The physician was intending to use the resolute onyx drug eluting stent to treat a lesion in the patient's ostium cx artery which had 90% lesion stenosis, no tortuosity and no calcification.No abnormalities were noted in relation to the anatomy.No damage was noted to the packaging and no issues were noted when removing the device from the hoop/tray.The device was inspected and negative prep was performed with no issues.The lesion was pre-dilated.The device did pass through a previously deployed stent.Resistance was not encountered when advancing the device and excessive force was not used during delivery.It was reported that the stent dislodged during delivery to/at the lesion.Unsuccessful snare attempts were made.The stent was not removed and being that the interventional wire position was lost, the stent had to be crushed up against the artery wall with a high pressure balloon.It was noted that the stent caught on one of the struts of a stent that was placed prior to the attempt of this deployment in the left main into the circumflex.Patient status is alive with no injury post procedure.

Manufacturer Narrative

Additional information: the previously deployed stent was a medtronic stent.The location of the stent that was crushed up against the artery wall was the circumflex artery.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The previously implanted stent was a drug eluting stent.The previously deployed stent was not deformed even after interaction with the stent that needed to be crushed up against the artery wall.Also the previously deployed stent did not appear deformed angiographically.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: 7128536
• MDR Text Key: 95226045
• Report Number: 9612164-2017-02015
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556812
• UDI-Public: 00643169556812
• 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: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2019
• Device Catalogue Number: RONYX25018UX
• Device Lot Number: 0008759510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2018
• Date Device Manufactured: 08/18/2017
• 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: 77 YR
• Patient Weight: 82