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

Catalog Number	RONYX30008UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	08/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patients medical history includes coronary artery disease.Physician intended to use a resolute onyx drug eluting stent to treat a severely calcified and mildly tortuous lesion in the mid rca.Abnormalities reported in relation to anatomy were reported as very anterior take off.The intended lesion had instent re-stenosis, previous non-mdt stent implanted.No difficulties were noted when removing the protective sheath.The device was inspected post removal of the sheath with no issues noted.Negative prep was not performed.There was no damage noted to packaging.There were no issues when removing the device from the hoop/tray.The lesion was not pre-dilated.The inflation device remained on neutral during delivery of the device.Resistance was observed and excessive force was used during attempted delivery.The physician observed that the device had difficulty in crossing a 70% in stent restenosis (which was calcified).Several attempts were made to cross the lesion with the stent prior to removal.After the stent would not cross this lesion, the stent became dislodged from the delivery system at the tip of the guide catheter during retrieval.The stent remained on the wire and was then deployed with use of a 1.5 balloon followed up by a 3.0 balloon.The stent was placed in the ostium of the rca.The target lesion was then ballooned and a non-mdt stent was placed.The patient is alive with no injuries.

• 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: 6837286
• Report Number: 9612164-2017-01201
• Device Sequence Number: 19022833
• Product Code: NIQ
• UDI-Device Identifier: 00643169556966
• UDI-Public: 00643169556966
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/02/2017

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: 03/14/2019
• Device Catalogue Number: RONYX30008UX
• Device Lot Number: 0008534798
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 09/01/2017
• 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: 70 YR