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

Catalog Number	RSINT30038UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 27th distal stent wraps with struts raised.Slight deformation was evident to the distal tip.The inner lumen patency was not verified with a 0.015 inch mandrel and 0.014 inch guidewire due to contrast in the lumen.(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use a resolute integrity rx drug eluting stent to treat a lesion located in the lad.There were there no abnormalities reported in relation to anatomy.There was no damage noted to packaging and there were no issues noted when removing the device from the hoop/tray.The device did not pass through a previously-deployed stent.It was reported that the stent detached/unravelled from the balloon after trying to advance stent to lesion.The procedure was completed with another resolute integrity device of the same size.The patient status post-procedure is alive with no injury.

• 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: 7012529
• Report Number: 9612164-2017-01579
• Device Sequence Number: 16518187
• Product Code: NIQ
• UDI-Device Identifier: 00643169037205
• UDI-Public: 00643169037205
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• 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): 11/09/2017

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: 05/08/2019
• Device Catalogue Number: RSINT30038UX
• Device Lot Number: 0008620558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 11/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1