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

Catalog Number	RSINT25018UX
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician was attempting to use a resolute integrity rx drug eluting stent to treat a moderately calcified and moderately tortuous proximal lad lesion exhibiting 80% stenosis.No damage noted to device packaging and no issues were noted when removing the devices from the hoop/tray.No issues noted removing the protective sheath.The device was inspected and negative prep performed with no issues noted.It was reported that the lesion was not pre-dilated.The device did not pass through a previously deployed stent.No resistance was encountered advancing the device and no excessive force used.During stent deployment the resolute integrity stent seemed to jump forward when the physician inflated the balloon to 16atm.A non-mdt guidewire was used and the stent was post dilated using a nc euphora to post dilate.No clinical sequelae reported.

• 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: 6188606
• Report Number: 9612164-2016-01336
• Device Sequence Number: 13516794
• Product Code: NIQ
• UDI-Device Identifier: 00643169037373
• UDI-Public: 00643169037373
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2016

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: 07/10/2017
• Device Catalogue Number: RSINT25018UX
• Device Lot Number: 0007644289
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2016
• Initial Report FDA Received Date: 12/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1