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

Catalog Number	RONYX35034UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	05/25/2018
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
One resolute onyx rx drug eluting stent was attempted to be used to treat a lesion in the rca.There was no damage noted to the device packaging.There were no issues removing the device from the hoop.The device was inspected with no issues.It was reported that the stent dislodged during delivery to the lesion.It is reported that the dislodged stent was removed with a snare.No patient injury is reported.
Additional Manufacturer Narrative
Product analysis summary: a snare loaded into a guide catheter was received with the delivery system.Delivery system returned with kinks on the distal shaft.The distal shaft appeared to be wrapped in a knot on the hypotube.Kinks were evident on the hypotube from 36.5cm to 82cm distal to the strain relief.The stent was not present on the balloon and did not return for analysis.Crimp impressions were visible on the exposed balloon surface.The balloon folds remained intact.The inner lumen patency could not be verified with a 0.015 inch mandrel due to kinking of the distal shaft.Numerous kinks were visible on the distal shaft from 12.6cm to 24cm proximal to the distal shaft.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: 7619362
• Report Number: 9612164-2018-01501
• Device Sequence Number: 11111886
• Product Code: NIQ
• UDI-Device Identifier: 00643169557123
• UDI-Public: 00643169557123
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 10/10/2018

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: 09/28/2019
• Device Catalogue Number: RONYX35034UX
• Device Lot Number: 0008814354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 10/10/2018
• 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