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

Catalog Number RONYX40022X

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A resolute onyx rx coronary drug eluting stent was used during a procedure to treat a lesion.There was no damage noted to the packaging.The device was inspected with no issues noted.Negative prep was performed with no issues noted.It was reported that after the stent was expanded the balloon would not deflate.The balloon catheter and the guide catheter had to be removed together.The patient was reported to be alive with no injury.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: it was not difficult to remove the protective sheath and packaging stylette.No resistance was noted while advancing the device to the lesion.Excessive force was not used.No inflation difficulties were noted.There was no deflation at all.The deflation difficulties were noted after the first inflation.The device was not moved or re-positioned in the lesion while inflated.It was difficult to remove the balloon catheter with guide catheter because the balloon was inflated.30% contrast, 70 % saline was used.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

Product analysis: the device was loaded into a non-medtronic guide catheter.The balloon had exited the guide catheter and appeared to be still inflated.It was not possible to remove the device from the catheter due to the inflated balloon.The guide catheter was cut immediately distal to the strain relief and the hypotube of the device was cut approx.55cm distal to the strain relief.The remainder of the device was then removed from the guide catheter.There was no damage to the distal tip.The proximal balloon bond was not necked.There was no evidence of stretching on the distal shaft.The transition shaft, immediately proximal to the exchange joint was kinked and twisted.The balloon was inflated using a makeshift luer and the balloon inflated and deflated slowly due to the damage to the transition shaft.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: 9586419
• MDR Text Key: 174920545
• Report Number: 9612164-2020-00215
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2021
• Device Catalogue Number: RONYX40022X
• Device Lot Number: 0009778369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2019
• 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