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

Catalog Number RONYX45015X

Device Problems Burst Container or Vessel (1074); Inflation Problem (1310); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a procedure a resolute onyx rx coronary drug eluting stent was used to treat a high grade in-stent stenosis located in the ostium rca.The device was inspected with no issues noted.Negative prep was performed.The lesion was pre-dilated with a nc solarice, a non-medtronic balloon and a deb in.Pact falcon.After dilatation with the deb there was still a restenosis it was reported that inflation difficulties were encountered during stent deployment and that stent dislodgement occurred during deployment.At the beginning of deployment everything seemed normal but suddenly the stent dislodged.An attempt was made to locate the stent.It was first located in the arm but was unable to be retrieved.The stent was then located in the renal artery and any attempt to retrieve the stent failed.The stent was left in the renal artery.Patient is alive with no further injury reported.

Manufacturer Narrative

Image analysis summary: an image shows the rca with a previously deployed stent in the ostium.A balloon is delivered inside the previously deployed stent and inflated.Further dilations are performed.The next images show attempts to search around the body for a dislodged stent.There were no images showing the attempted delivery of this stent or the reported inflation difficulties encountered when deploying the stent.Attempts are made to retrieve the dislodged stent.The dislodged stent moves to the renal artery and is found under fluoroscopy.The final images show the dislodged stent in the renal artery.The dislodged stent was not removed.Product analysis summary: a kink was evident on the hypotube.The stent was not present on the balloon and did not return for analysis.The delivery system returned with blood visible in the balloon and inflation lumen.The balloon folds were partially expanded.Crimp impressions were visible on the exposed balloon surface.The delivery system was placed in the waterbath to disperse the blood and aid inflation.Upon removal, the balloon failed negative prep.On pressurisation of the delivery system, liquid was observed exiting the balloon distal cone.The balloon failed to maintain pressure.Upon visual inspection of the delivery system, there was a short longitudinal tear on the balloon material on the distal cone.Lead in scratches were not evident proximal or distal to the tear site.The balloon material was jagged and uneven at the tear site.The inner lumen patency was verified with a 0.015 inch mandrel.There was no other damage evident to the remainder of the delivery system.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

High grade in-stent stenosis occurred in a previously implanted resolute integrity coronary drug eluting stent located in the ostium rca.No resistance was noted while advancing the resolute onyx device to the lesion.It was only possible to inflate the resolute onyx to approx 1-2 atm.The same inflation device was used for all devices that were used in this procedure, with no inflation difficulties noted.The physician assessed that the inflation difficulty was not due to vessel morphology, or the inflation pressure applied.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: 8747387
• MDR Text Key: 149627097
• Report Number: 9612164-2019-02596
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2020
• Device Catalogue Number: RONYX45015X
• Device Lot Number: 0009342476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2019
• Date Device Manufactured: 09/25/2018
• 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: 74 YR
• Patient Weight: 82