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	12/14/2017
Type of Reportable Event	Malfunction
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 integrity drug eluting stent to treat a non-tortuous lesion with 80% stenosis in the proximal lad.There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop/tray.The device was inspected with no issues.Negative prep was not performed.The device did not pass through a previously deployed stent.It is reported that the stent strut got lifted up.The procedure was completed using a rsint30034ux device.No patient injury is reported.
Additional Manufacturer Narrative
Product analysis: the stent was positioned on the balloon between the marker bands as per specifications.Misalignment to the struts was evident to the 5th and 9th distal stent wraps.Deformation was evident to the distal tip, it was kinked.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: 7185146
• Report Number: 9612164-2018-00058
• Device Sequence Number: 16632175
• Product Code: NIQ
• UDI-Device Identifier: 00643169037205
• UDI-Public: 00643169037205
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 03/07/2018

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: 03/31/2019
• Device Catalogue Number: RSINT30038UX
• Device Lot Number: 0008561123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 01/12/2018
• Supplement Report FDA Received Date: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 61