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

Model Number	RONYX30026UX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: the device returned with a detachment on the hypotube at the distal hypotube markerband.The hypotube material was oval and jagged on both sides of the detachment site.Kinks were evident on the hypotube proximal and distal to the detachment site.Torsional kinking was evident to the distal shaft.The inner lumen could not be verified with a 0.015 inch mandrel due to the torsional kinking.The stent was positioned between the markerbands as per specification.No stent deformation was noted.No deformation was evident to the distal tip.No other damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: resolute onyx rx coronary drug eluting stent was used to treat a mildly tortuous, moderate calcified lesion in the mid lad.The lesion was pre-dilated.Resistance was noted during withdrawal of the stent with excessive force used.It was reported that the catheter broke in half during withdrawal of the device, while the stent was in the guide catheter in the patient.The entire catheter and stent were removed in a single piece.If information is provided in the future, a supplemental report will be issued.
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 one resolute onyx rx coronary drug eluting stent to treat a mildly calcified lesion.The device was inspected with no issues noted.Negative prep was performed with no issues.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 the catheter broke in half during delivery through the vessel.It was stated that it was difficult to cross the lesion with the stent and much force and torque was used.The catheter broke in half after the force and torque techniques used.The entire catheter and stent was removed from the patient's coronary artery.The patient was reported to be alive with no injury.

• 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: 9715887
• Report Number: 9612164-2020-00735
• Device Sequence Number: 14235193
• Product Code: NIQ
• UDI-Device Identifier: 00643169557017
• UDI-Public: 00643169557017
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Followup,Followup
• Report Date (Section B): 04/20/2020

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: 11/25/2021
• Device Model Number: RONYX30026UX
• Device Catalogue Number: RONYX30026UX
• Device Lot Number: 0010033512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 02/14/2020; 03/09/2020; 04/16/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 03/04/2020; 03/25/2020; 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1