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

Catalog Number	RSINT25022UX
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the stent was not present on the balloon and did not return for analysis.The balloon folds were partially expanded.Crimp impressions were visible on the exposed balloon surface.Deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.The distal shaft was kinked approx.6.5cm proximal to the distal tip.
Event or Problem Description
It was reported that the physician was attempting to use a resolute integrity rx drug eluting stent to treat a lesion in the lad.No damage was noted to the packaging and no issues were noted when removing the device from the hoop.The device was inspected with no issues noted.Negative prep was performed.It is reported that the stent would not enter the guideliner and it crumpled up on itself while trying to go through the guideliner.Stent displacement occurred while in the patient and the stent remained on the delivery system when removal from the body.The surgical team took the stent off the device to inspect it once it was removed from the body.It was reported that this was a very difficult case and the patient had been denied surgery.The procedure was completed using another resolute integrity device.Patient is ok.

• 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: 6844940
• Report Number: 9612164-2017-01226
• Device Sequence Number: 13469152
• Product Code: NIQ
• UDI-Device Identifier: 00643169037380
• UDI-Public: 00643169037380
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 08/08/2017

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: 10/03/2018
• Device Catalogue Number: RSINT25022UX
• Device Lot Number: 0008243801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 09/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1