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

Catalog Number	RONYX22538UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/09/2018
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 2.25 x 38 mm resolute onyx rx drug eluting stent to treat a moderately calcified and tortuous mid cx lesion exhibiting 75% stenosis.The lesion was reported to have been dissected by a non-medtronic wire.There was no damage noted to packaging.No issues removing the device from the hoop.The device was inspected and negative prep performed with no issues noted.The lesion was pre-dilated.During the procedure, the device did not pass through a previously deployed stent.Resistance was encountered during advancement but excessive force was not used.It was reported that the physician attempted to cross the lesion but the device failed to cross.The physician then tried using a 5fr guideliner and still could not get the stent to cross.During removal the stent got stuck in the guideliner.It was reported that the stent dislodged.The stent was removed via the guideliner.The physician then tried a 2.25x12 resolute onyx device and this did not cross either.The procedure was completed.No patient injury reported.
Additional Manufacturer Narrative
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: 7322955
• Report Number: 9612164-2018-00473
• Device Sequence Number: 18869762
• Product Code: NIQ
• UDI-Device Identifier: 00643169556775
• UDI-Public: 00643169556775
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 10/04/2018

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: 10/17/2019
• Device Catalogue Number: RONYX22538UX
• Device Lot Number: 0008839425
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 06/29/2018; 08/08/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 07/23/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 72