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

Catalog Number	RSINT30015UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use a resolute integrity drug eluting stent.No damage was noted to packaging and no issues noted when removing the device from the hoop/tray.The device was inspected and negative prep was performed with no issues found.The lesion was pre-dilated.It was reported that stent deformation occurred in-vivo during positioning/advancement.When the device was removed, a flare was observed.The device did not pass through a previously-deployed stent, no resistance was encountered when advancing the device and no excessive force was used during delivery.A new resolute stent was placed to replace the 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: 6574636
• Report Number: 9612164-2017-00604
• Device Sequence Number: 16172758
• Product Code: NIQ
• UDI-Device Identifier: 00643169037502
• UDI-Public: 00643169037502
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 07/09/2018

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: 12/05/2018
• Device Catalogue Number: RSINT30015UX
• Device Lot Number: 0008402823
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 05/18/2017
• Supplement Report FDA Received Date: 07/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1