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

Catalog Number	RSINT25030UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 1-4th distal stent wraps with struts raised, bunched and stretched.No deformation was evident to the distal tip.The inner lumen patency was verified.(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use a resolute integrity rx coronary drug eluting stent to treat a mildly calcified and mildly tortuous lesion located at the distal right coronary artery exhibiting 95% stenosis.Abnormalities were reported in relation to anatomy in that a previous stent was implanted.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop/tray.The device was inspected with no issues identified.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did pass through a previously-deployed stent.Resistance was encountered when advancing the device and excessive force was not used during delivery.It was reported that the stent deformed during positioning.It was described that the angle of the al1 guide was an acute angle to the vessel and created an extreme angle into the vessel.The stent incurred some resistance upon crossing that angle and this possibly lifted or damaged the stent strut.The physician stated that the stent damage was noted and the device was replaced with a new rsint25030ux which crossed successfully and the procedure was completed.Patient status post-procedure is alive with no injury.

• 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: 7047924
• Report Number: 9612164-2017-01639
• Device Sequence Number: 19195006
• Product Code: NIQ
• UDI-Device Identifier: 00643169037526
• UDI-Public: 00643169037526
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2017

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: 06/09/2019
• Device Catalogue Number: RSINT25030UX
• Device Lot Number: 0008671575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1