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

Catalog Number	RONYX35038UX
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure an attempt was made to use a 3.5x38mm resolute onyx rx coronary drug eluting stent to treat a mildly tortuous, severely calcified lesion exhibiting 95% stenosis located in the proximal-mid obtuse marginal (om).The device was inspected with no issues noted.Negative prep was performed without issue.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Excessive force was not used during delivery.It was reported that an attempt was made to deliver the 3.5x38mm resolute onyx stent to the om using a guideliner to facilitate the delivery, however the stent failed to cross the lesion.When pulling back the device the stent dislodged from the delivery system into the vessel.The guideliner was advanced over the stent and removed out of the body along with the guideliner.As this was the last 3.5x38mm resolute onyx stent available, the procedure was successfully completed using a 3.5x34mm resolute onyx stent overlapped with another resolute onyx stent that was later implanted in the proximallcx in order to make up for the length.The patient was reported to be alive with no injury.
Additional Manufacturer Narrative
Product analysis summary: the device returned for evaluation.A stopcock was attached to the luer of the delivery system.A kink was evident on the hypotube.Deformation was evident to the dislodged stent.Crimp impressions were visible on the exposed balloon surface.The balloon folds remained intact.Slight deformation was evident to the distal tip.The inner lumen could not be verified with a 0.015 inch mandrel most likely due to hardened blood in the guidewire lumen.No other damage evident to the remainder of the delivery system.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8460401
• Report Number: 9612164-2019-01082
• Device Sequence Number: 16897411
• Product Code: NIQ
• UDI-Device Identifier: 00643169557130
• UDI-Public: 00643169557130
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/07/2021
• Device Catalogue Number: RONYX35038UX
• Device Lot Number: 0009526190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1