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

Catalog Number	RSINT35009UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	01/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the physician was attempting to you a resolute integrity rx drug eluting stent to treat a moderately calcified and severely tortuous mid lad lesion exhibiting 90% stenosis.No damage was noted to the device packaging and no issues noted removing the device from the hoop tray.No issues noted when removing the protective sheath.The device was inspected with no issues noted.Negative prep was not performed.The physician pre-dilated the lesion.During the procedure, the device passed through a previously deployed stent.No excessive force was used during delivery.Inflation device remained on neutral pressure during delivery of the device.It is reported that the resolute caught on a strut and dislodged when the physician pulled back device.Stent dislodgement occurred during delivery to/at lesion.The physician crushed the stent against the distal lad wall with another 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: 6335114
• Report Number: 9612164-2017-00181
• Device Sequence Number: 1709837
• Product Code: NIQ
• UDI-Device Identifier: 00643169037090
• UDI-Public: 00643169037090
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2017

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: 09/01/2018
• Device Catalogue Number: RSINT35009UX
• Device Lot Number: 0008201192
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2017
• Initial Report FDA Received Date: 02/16/2017
• 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