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

Catalog Number	RSINT25026UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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 tortuous proximal cx lesion exhibiting 90% stenosis.No damage was noted to device packaging and no issues noted removing the device from the hoop/tray.The device was inspected and negative prep with no issues noted.The lesion was pre-dilated.During the procedure, the device did not pass through a previously deployed stent.Resistance was encountered when advancing the device and no excessive force was used.It was reported that the device failed to cross the target lesion.The physician removed the device and it was noted that the stent strut was lifted up on the distal end.The physician used another stent which crossed and deployed without incident.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: 6313570
• Report Number: 9612164-2017-00120
• Device Sequence Number: 543728
• Product Code: NIQ
• UDI-Device Identifier: 00643169037519
• UDI-Public: 00643169037519
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/17/2017

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: 06/10/2017
• Device Catalogue Number: RSINT25026UX
• Device Lot Number: 0007611265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2017
• Initial Report FDA Received Date: 02/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1