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

Catalog Number	RSINT35038UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2018
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 was intended to be used to treat a patient.No issues were encountered when prepping and preparing the device.The lesion was pre-dilated.It is reported that a resolute integrity stent failed to cross a lesion.Upon removal of the device from the patient, the stent was noted to have damaged struts.No patient injury, issue or complication is reported.
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: 7240748
• Report Number: 9612164-2018-00199
• Device Sequence Number: 11021938
• Product Code: NIQ
• UDI-Device Identifier: 00643169037298
• UDI-Public: 00643169037298
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2018

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: 09/13/2018
• Device Catalogue Number: RSINT35038UX
• Device Lot Number: 0008217268
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR