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

Catalog Number	RSINT22514UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The physician intended to use a resolute integrity rx drug eluting stent to treat a severely calcified and non-tortuous lesion.There were no abnormalities in relation to anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from hoop/tray.The lesion was pre-dilated.No resistance was encountered when advancing the device to the lesion.The device did not pass through a previously-deployed stent.It was reported that the guide liner wrapped around the stent and crushed it.The entire stent was removed with the guide liner and nothing was deployed in the body.Patient status post procedure is alive with no injury.

• 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: 7066287
• Report Number: 9612164-2017-01684
• Device Sequence Number: 13755912
• Product Code: NIQ
• UDI-Device Identifier: 00643169037410
• UDI-Public: 00643169037410
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 11/29/2017

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: 08/18/2018
• Device Catalogue Number: RSINT22514UX
• Device Lot Number: 0008184895
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1