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

Catalog Number RONYX22522UX

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/12/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

During the procedure an attempt was made to use a resolute onyx rx coronary drug eluting stent (2.25 x 22mm) to treat a mildly tortuous and moderately calcified lesion in the distal rca.There were no issues noted removing the device from the hoop.The lesion was pre-dilated.The device did pass through a previously-deployed stent.Resistance was encountered when advancing the device.Excessive force was used during delivery.There was a proximal lesion in the rca as well as a mid to distal lesion in the rca.The proximal lesion was pre-dilated and stented using 3.0 x 22mm resolute onyx, and post-dilated with an 3.5 nc euphora balloon.The distal lesion was then pre-dilated with a 2.0 euphora balloon and the 2.25 x 22mm stent was advanced through the proximal rca/stent to the mid-distal part of the rca.The stent could not be advanced far enough down the vessel for placement, and an attempt was made to pull back the stent to further pre-dilate the distal lesion before placing the stent.When the stent was pulled back, the stent became dislodged from the balloon when it got caught on the distal edge of the proximal 3.0 x 22 stent.A non medtronic balloon was used and was able to carry and advance the dislodged stent down the rca to the distal lesion.Multiple nc euphora balloons were then used in the stent to inflate and expand the dislodged stent and oppose it to the vessel wall.Another stent (2.25 x 12mm) was implanted over the dislodged stent at 20 atmospheres.No patient injury was reported.

• 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: 8334610
• MDR Text Key: 135995271
• Report Number: 9612164-2019-00498
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556737
• UDI-Public: 00643169556737
• 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
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2020
• Device Catalogue Number: RONYX22522UX
• Device Lot Number: 0009379540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 02/13/2019
• Date Device Manufactured: 10/15/2018
• 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