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

Catalog Number	RONYX22534UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/17/2017
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
The physician intended to use a resolute onyx drug eluting stent to treat a moderately tortuous, severely calcified lesion with 80% stenosis in the mid rca.Abnormalities are reported in relation to the anatomy whereby the degree of calcification was not fully appreciated prior to stenting.There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device and excessive force was not used.The inflation device remained on neutral.It was reported that a section of the rca was calcified prior to a previous stent and the new lesion.Despite pre-dilating the area with a 2.0x8 mm non-mdt balloon, the onyx device failed to cross the calcification and dislodged.No attempt was made to remove the dislodged stent.The dislodged stent was deployed proximal to the lesion where it dislodged.A series of 9 balloons, five of them being medtronic balloons of increasing size were used to increase the diameter of the stent to approximately 3.0 mm.There was no complaint against the mdt balloons used during the procedure.No patient injury was reported.

• 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: 7120453
• Report Number: 9612164-2017-01959
• Device Sequence Number: 1210642
• Product Code: NIQ
• UDI-Device Identifier: 00643169556768
• UDI-Public: 00643169556768
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 12/15/2017

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: 08/30/2019
• Device Catalogue Number: RONYX22534UX
• Device Lot Number: 0008776396
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/15/2017
• 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: 77 YR