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

Catalog Number	RSINT22512UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the stent was positioned on the balloon between the marker bands as per specifications.There was deformation to the 8th distal stent wrap with struts raised and overlapping.There was slight deformation to the distal tip.The distal shaft was kinked approx.1cm distal to the guidewire entry port.
Event or Problem Description
The physician was attempting to use a resolute integrity rx drug eluting stent.The target lesion was in the distal rca.The target lesion was pre-dilated.There was no damage to packaging.The packaging was sealed.The device was inspected before use.It was noted to be in good working order with no defects coming out of the package.Resistance was encountered when attempting to advance the device through a proximal calcified area of the rca.This proximal area wasn't determined as an issue while pre-ballooning the true target distal lesion.The device wouldn't cross the proximal rca, so it didn't get to the target lesion.Excessive force was not used.It was reported that the device was damaged during use.When it was removed, it was noted that stent struts were sticking out and bent.No patient injury reported.The target lesion was treated with another resolute integrity stent.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6272319
• Report Number: 9612164-2017-00063
• Device Sequence Number: 10943063
• Product Code: NIQ
• UDI-Device Identifier: 00643169037403
• UDI-Public: 00643169037403
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 01/04/2017

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: 07/11/2018
• Device Catalogue Number: RSINT22512UX
• Device Lot Number: 0008135219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: 01/04/2017
• Initial Report FDA Received Date: 01/24/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1