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

Catalog Number RONYX20012UX

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/01/2019

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 to treat a non tortuous and severely calcified lesion located in the distal lm.The device was inspected with no issues noted.The lesion was not pre-dilated.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device.Excessive force was used during delivery.It was reported that stent dislodgement occurred during removal following failed delivery.The dislodged stent was removed using a snare.No patient injury was reported.

Manufacturer Narrative

Device evaluation summary: a stopcock was attached to the luer of the delivery system.The dislodged stent was loaded on to the guidewire.Severe deformation was evident to the dislodged stent.The balloon folds were partially expanded.Crimp impressions were visible on the exposed balloon surface.There was no deformation evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.There was no other damage evident to the remainder of the device.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: 8334441
• MDR Text Key: 135989567
• Report Number: 9612164-2019-00492
• Device Sequence Number: 1
• Product Code: NIQ
• 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
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RONYX20012UX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2018
• 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
• Patient Age: 87 YR
• Patient Weight: 90