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

Model Number	RONYX40018UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2019
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
An attempt was made to use a resolute onyx (4.00 x 18) rx coronary drug eluting stent to treat a bifurcation in the mid circumflex artery /obtuse marginal.The lesion exhibited 90% stenosis, mild tortuosity and mild calcification.The device was inspected, and negative prep was carried out prior to use with no issues noted.The lesion was pre-dilated.The device passed through a previously deployed stent.Resistance was encountered advancing the device and excessive force was used during delivery.A 3.5 x 15 resolute onyx was firstly implanted in the ostium of the obtuse marginal.A "crush technique" was used to deploy the 3.5 x 15 stent.A 6f telescope guide extension catheter was then advanced to the crushed stent.It was reported that the resolute onyx (4.00 x 18) device was advanced however was unable to cross the lesion.Stent dislodgement occurred during removal following failed delivery.The stent was stuck in the end of the 6f telescope.The telescope, guide catheter, and stent delivery balloon were withdrawn as a unit out of the body.The procedure was completed following re-wiring, pre-dilation and the use of kissing balloons which enabled stent delivery.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: there were no issues noted when removing the protective sheath from the 4.00x18mm resolute onyx stent.The inflation device remained on neutral pressure during delivery of the device.The device was inspected prior to use.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The dislodged stent was returned in the lumen of a telescope gec.The stent delivery was not returned for analysis.The distal struts of the stent which were exposed outside the telescope gec appeared deformed.The stent was removed easily from the telescope gec by pulling it distally, no resistance was encountered.On removal, the stent appeared to be kinked.No other deformation was evident to the stent.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the stent dislodged inside the end of the telescope.The dislodged stent was removed with the telescope.The procedure was completed following re-wiring, pre-dilation and successful delivery of a new 4.0x18mm resolute onyx device.Kissing balloon technique was then used in the circumflex and om1.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.

• 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: 9202362
• Report Number: 9612164-2019-04404
• Device Sequence Number: 13565187
• Product Code: NIQ
• UDI-Device Identifier: 00643169557178
• UDI-Public: 00643169557178
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 02/21/2020

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: 04/07/2021
• Device Model Number: RONYX40018UX
• Device Catalogue Number: RONYX40018UX
• Device Lot Number: 0009684483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 10/17/2019; 10/14/2019; 11/29/2019; 02/20/2020
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 11/11/2019; 11/13/2019; 12/12/2019; 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1