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

Catalog Number	RSINT22514UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2017
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 severely calcified and moderately tortuous ostium rca lesion.No damage to device packaging and no issues removing the device from the hoop / tray.The device was inspected with no issues noted.The lesion was pre-dilated.During the procedure, the stent did not pass through a previously implanted stent.Resistance was encountered when advancing the device and no excessive force was used.The stent failed to cross the target lesion and was removed from the patient.No intervention was required.The physician dilated the lesion and picked up the resolute to make another attempt but noted that the stent was not on the delivery system.They searched the field and searched the patient's body thoroughly under fluoro but could not locate the stent.No patient injury 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: 6700478
• Report Number: 9612164-2017-00867
• Device Sequence Number: 57710
• Product Code: NIQ
• UDI-Device Identifier: 00643169037410
• UDI-Public: 00643169037410
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2017

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: 03/10/2019
• Device Catalogue Number: RSINT22514UX
• Device Lot Number: 0008529568
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2017
• Initial Report FDA Received Date: 07/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1