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

Catalog Number	RONYX22522UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2018
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 drug eluting stent to treat a moderately tortuous lesion in the proximal left main.No damage noted to packaging.No issues were noted when removing the device from the hoop.No difficulties were noted when removing the protective sheath.The device was inspected with no issues noted.The inflation device remained on neutral pressure during delivery of the device.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It is reported that stent dislodgement occurred during delivery to the lesion.The dislodged stent was removed from the patient through a non-mdt catheter.Intervention was not required.No patient injury is reported.
Additional Manufacturer Narrative
Negative prep was not performed.The lesion was pre-dilated.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: 7435475
• Report Number: 9612164-2018-00801
• Device Sequence Number: 333955
• Product Code: NIQ
• UDI-Device Identifier: 00643169556737
• UDI-Public: 00643169556737
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/05/2018

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: 07/27/2019
• Device Catalogue Number: RONYX22522UX
• Device Lot Number: 0008732949
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1