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

Catalog Number	RSINT22530UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	01/23/2017
Type of Reportable Event	Serious Injury
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, severely tortuous lad lesion exhibiting 100% stenosis (cto).No damage was noted to the device packaging or issues noted removing the device from the hoop / tray.The device was inspected and negative prep was performed without issue.The lesion was pre-dilated.During the procedure, the device did not pass through a previously deployed stent.Resistance was encountered while advancing the device but no excessive force used.Stent dislodgement was reported to have occurred during advancement and pull back in the lesion.It was reported that the cto was fixed, but that the dislodged stent ended up in the iliac artery and couldn't be removed.An attempt had been made to snare the stent.

• 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: 6348636
• Report Number: 9612164-2017-00198
• Device Sequence Number: 933867
• Product Code: NIQ
• UDI-Device Identifier: 00643169037335
• UDI-Public: 00643169037335
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2018
• Device Catalogue Number: RSINT22530UX
• Device Lot Number: 0008199742
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2017
• Initial Report FDA Received Date: 02/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention