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

Catalog Number	RSINT30034UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2018
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
A resolute integrity drug eluting stent device was attempted to be used to treat in-stent restenosis in the om1.The lesion was pre-dilated with a 2.75 x 15mm euphora balloon catheter.It is reported that the stent failed to cross the lesion and stent strut damage was seen on removal of the device.The procedure was completed using a non-medtronic stent.No patient injury is reported.
Additional Manufacturer Narrative
The in-stent restenosis was in a non-medtronic stent.The lesion was heavily calcified, with 80% stenosis and medium tortuosity.The device was not defective from the package.More than normal force was used during the delivery.The lesion was ballooned again and a non-medtronic stent was able to cross.If information is provided in the future, a supplemental report will be issued.
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: 8208020
• Report Number: 9612164-2019-00008
• Device Sequence Number: 334578
• Product Code: NIQ
• UDI-Device Identifier: 00643169037199
• UDI-Public: 00643169037199
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Followup
• Report Date (Section B): 03/11/2019

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: 07/03/2019
• Device Catalogue Number: RSINT30034UX
• Device Lot Number: 0008699146
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 01/18/2019; 03/08/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 02/14/2019; 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1