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

Catalog Number	RSINT30018UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2018
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
It was reported that a resolute integrity drug eluting stent was frayed.This occurred in vivo after balloon angioplasty.No injury to the patient was reported.
Additional Manufacturer Narrative
Evaluation summary: the stent was positioned on the balloon between the marker bands as per specifications.Misalignment was evident to the 1st stent wrap, with strut raised.Deformation was evident to the distal tip, with tip appearing torn.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.
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: 7276039
• Report Number: 9612164-2018-00363
• Device Sequence Number: 19151448
• Product Code: NIQ
• UDI-Device Identifier: 00643169037151
• UDI-Public: 00643169037151
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 05/31/2019
• Device Catalogue Number: RSINT30018UX
• Device Lot Number: 0008657150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 04/03/2018; 06/25/2018; 08/08/2018
• Initial Report FDA Received Date: 02/16/2018
• Supplement Report FDA Received Date: 05/01/2018; 07/23/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1