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

Catalog Number RONYX35022X

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2017

Event Type  malfunction  

Event Description

The physician used a 3.5mm resolute onyx drug eluting stent to treat a lesion in the distal lad within the proximal left main coronary artery.The physician treated the medina ¿ 1,1,0.Mid and distal lms disease plus ostial and proximal lad disease.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues.The device did not pass through a previously deployed stent.The lesion was predilated.It is reported that the device was taken to stent the left main into the lad.The maximum diameter of the lad was 3.5mm and the left main was no bigger than 4.5mm.According to resolute onyx compliance chart, the maximum stent internal diameter for the 3.5mm stents is 4.75mm and so it was decided to post dilate the proximal segment of the stent in the left main to 4.5mm using non-mdt balloons.Intravascular imaging showed that the stent could not reach a diameter of greater than 4mm.Further intervention was not required.

Manufacturer Narrative

Non medtronic guidewires were used during the procedure.The lesion was pre-dilated with 2.0 balloon then ivus was carried out to determine size.The lesion was then pre-dilated with a 3.0 balloon.The mid lad was stented with a 2.75 x 32mm non medtronic des device the stent was deployed at 14 atm.The stent was deployed but there was a size mismatch between the lad and the lms hence the proximal end needed to be post dilated.Post dilation was carried out with a 4.0 x12 non mdt nc balloon post dilated at 11 atm then 18 atm.5.0 x 6mm nc non mdt balloon inflated at 10 atm then 14 atm.6.0 x 8mm nc non mdt balloon inflated at 12 atm.There was a dissection in the distal cx caused by the non-mdt wire.This has been left to be managed conservatively.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: severely calcified lesion in the left main / lad is visible.The vessel had >180 degrees of hyperechoic signal (calcium).Virtual histology confirmed calcified lesion (white spots) were also present.Calcium was also present on the baseline images.It can be seen that it was not possible to modify the plaque after several attempts with poba.No device failure was observed.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: 7095242
• MDR Text Key: 94514932
• Report Number: 9612164-2017-01819
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P160043
• 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,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2019
• Device Catalogue Number: RONYX35022X
• Device Lot Number: 0008689270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2018
• Date Device Manufactured: 06/26/2017
• 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 Age: 65 YR
• Patient Weight: 89