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

Model Number RONYX35018UX

Device Problems Calcified (1077); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2018

Event Type  malfunction  

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 one resolute onyx drug eluting stent to treat a moderately tortuous and severely calcified lesion located in the mid right coronary artery, exhibiting 80% stenosis.There were no abnormalities reported in relation to anatomy.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 identified.Negative prep was not performed.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that the stent initially did not cross the lesion and on removal from the patient, the stent was partially crushed.The stent remained on the balloon but was severely deformed on the delivery system.The procedure was completed using a medtronic stentsuccessfully.Patient status post-procedure is alive with no injury.

Manufacturer Narrative

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

Manufacturer Narrative

Product analysis summary: there was a kink on the hypotube 12.5cm distal to the strain relief.The stent had moved distally on the balloon and was not positioned on the balloon between the marker bands as per specifications.Deformation was evident to the distal stent wraps with struts raised and bunched.No deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.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: 7693280
• MDR Text Key: 114676863
• Report Number: 9612164-2018-01772
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557086
• UDI-Public: 00643169557086
• 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: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2019
• Device Model Number: RONYX35018UX
• Device Lot Number: 0008918282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2017
• 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: 79 YR