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

Catalog Number	RSINT30015UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the distal shaft was kinked 14.4cm distal to the guidewire entry port.The stent was positioned on the balloon between the marker bands as per specifications.There was deformation to the 1st distal stent wrap with struts raised.There was deformation to the distal tip.(b)(4).
Event or Problem Description
The physician intended to use two resolute integrity 3.0 x 15mm drug-eluting stents.No difficulties were noted when removing the device from the hoop.There was no damage noted to the packaging, i.E.Shelf carton, hoop/ tray.It was confirmed that the stents were completely in tact with no issues noted when removed from the sheath.Negative prep was performed on the devices.The stents were reported to be deformed when in the body being pushed up against heavily calcium in a cto vessel, following many pre-dilations.

• 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: 6176517
• Report Number: 9612164-2016-01305
• Device Sequence Number: 13556467
• Product Code: NIQ
• UDI-Device Identifier: 00643169037502
• UDI-Public: 00643169037502
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2016

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: 06/03/2018
• Device Catalogue Number: RSINT30015UX
• Device Lot Number: 0008084118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2016
• Initial Report FDA Received Date: 12/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1