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

Catalog Number RONYX40008X

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 09/20/2016

Event Type  malfunction  

Manufacturer Narrative

Image review: review of procedural images confirmed the lesion at the ostium of the left main.It appears that the stent may have been deployed with the proximal end extending into the aorta possibly due to the angulation of the lm in relation to the aorta.Following post dilatation the guide catheter appears to be deep seated and extending inside the stent.The images capture retraction and subsequent deployment of the stent in the brachial artery.(b)(4).

Event Description

It was reported that the physician was attempting to treat a non- calcified and non-tortuous lm ostium lesion exhibiting 70% stenosis.The physician attempted to use a resolute onyx drug eluting stent.No damage was noted to the device packaging or issues noted when removing the device from the hoop/tray.The device was inspected with no issues noted.Negative prep was performed successfully.The lesion was not pre-dilated.During the procedure, the device did not pass through a previously deployed stent.No resistance was encountered during delivery or excessive force used.The inflation device remained on neutral pressure during delivery of the device.The stent was implanted in the target lesion at 20 atm.The physician used the balloon of the stent to post-dilate the stent and an nc balloon.It was reported that the stent moved centrally away from the lesion and around the guiding catheter in the aorta.The catheter, the guide wire and the inflated 5.0 nc euphora balloon were pulled back all together in an effort to move the stent into the brachial artery, where it was implanted.The stent had reached a certain point into the brachial where no more movement was possible and it was implanted at that point using the 5.0 nc euphora balloon.The target lesion was subsequently treated with a 4x12mm resolute onyx drug eluting stent.¿please note that this device (resolute onyx) is not marketed in the united states; however, it is similar to the united states marketed device (resolute integrity).This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.¿.

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: 6036489
• MDR Text Key: 57720576
• Report Number: 9612164-2016-01101
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2017
• Device Catalogue Number: RONYX40008X
• Device Lot Number: 0007653471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2016
• Date Device Manufactured: 07/16/2015
• 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: 80 YR
• Patient Weight: 95