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

Catalog Number	RONYX22508UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	03/21/2018
Type of Reportable Event	Serious Injury
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 lesion in the distal rca.It was reported that there was not much calcification but the lesion was very tight, with 90% stenosis, and an approx 90 degree bend.There was no damage noted to the device packaging.The device was inspected with no issues.No difficulties were reported regarding removing the protective sheath.Negative prep was performed.The lesion was pre-dilated.The device did pass through a previously-deployed stent.The resolute onyx was intended to be implanted distal to a previous stent.Resistance was encountered when advancing the device.The stent could not be advanced distally enough with reasonable push and therefore it was decided to bring it back and do more predilatation.Excessive force was not used during delivery.The inflation device remained on neutral pressure during delivery of the device.Attempts were made to deliver the stent to the lesion, twice, without success.The physician removed the device after the second attempt and changed the guide catheter.It is reported that when attempting to cross for the third time the stent dislodged.The dislodged stent was retrieved using two wire trapping technique.The wires, dislodged stent, and the guide were removed as a unit, for removal of the dislodged stent.A new guide was reengaged and a new stent was delivered.No patient injury is reported.
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: 7435607
• Report Number: 9612164-2018-00805
• Device Sequence Number: 11173275
• Product Code: NIQ
• UDI-Device Identifier: 00643169556690
• UDI-Public: 00643169556690
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/02/2020
• Device Catalogue Number: RONYX22508UX
• Device Lot Number: 0008933669
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 09/03/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 88