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

Catalog Number	RSINT25014UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: a stopcock returned attached to the luer of the device.Kinks were evident along the hypotube.There was a kink on the distal shaft 8.8cm distal to the guidewire entry port.The stent was positioned on the balloon between the marker bands as per specifications.There was deformation to the 10th distal stent wrap with struts raised.There was slight deformation to the distal tip.Inner lumen patency was verified with a 0.015 inch mandrel.
Event or Problem Description
It was reported that the physician was attempting to use a resolute integrity rx drug eluting stent.No issues noted to device packaging and no issues removing the device from the hoop/tray.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered during delivery.No excessive force was used.It was reported that the physician attempted to position the stent in the artery, but could not cross the stent and it pushed the guide out.The physician believed that the stent may have caught on the guide.The physician ballooned the lesion and was about to put the stent back in and noticed that the struts were sticking up.It is unknown if it came out of the package that way or if it caught on the guide and deformed the stent.Another resolute was used to complete the procedure.No patient injury reported.

• Brand Name: RESOLUTE INTEGRITY RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6571575
• Report Number: 9612164-2017-00598
• Device Sequence Number: 662691
• Product Code: NIQ
• UDI-Device Identifier: 00643169037366
• UDI-Public: 00643169037366
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P100113
• 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
• Report Date (Section B): 04/18/2017

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: 04/21/2018
• Device Catalogue Number: RSINT25014UX
• Device Lot Number: 0008022747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2017
• Initial Report FDA Received Date: 05/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1