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

Catalog Number	RSINT30030UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During the procedure, an attempt was made to use one resolute integrity rx coronary drug eluting stent to treat a calcified lesion located in a mildly tortuous right coronary artery.There were no abnormalities in relation to anatomy.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 device did not pass through a previously-deployed stent.No resistance was noted while advancing the device to the lesion.The lesion was pre-dilated.It was reported that stent deformation occurred in vivo during positioning.The device was removed through the guide catheter.Another resolute integrity of the same size and lot was then used.Patient status post-procedure is alive with no injury.
Additional Manufacturer Narrative
Evaluation summary: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 1st and 2nd stent wraps with struts raised and bunched.Deformation was evident to the distal tip.The guidewire lumen patency could not be verified with a 0.015 inch mandrel most likely due to hardened blood.If information is provided in the future, a supplemental report will be issued.

• 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: 7493477
• Report Number: 9612164-2018-00998
• Device Sequence Number: 11116898
• Product Code: NIQ
• UDI-Device Identifier: 00643169037182
• UDI-Public: 00643169037182
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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,Followup
• Report Date (Section B): 08/16/2018

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: 03/29/2019
• Device Catalogue Number: RSINT30030UX
• Device Lot Number: 0008557333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR