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

Catalog Number	RSINT35034UX
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2019
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
An attempt was made to use one resolute integrity rx coronary drug eluting stent.It was reported that during the procedure, a leak was detected in the device when negative pressure was pulled.When getting ready to deploy the stent in the body, air was noted when pulling back on the indeflator.The stopcock was then closed off to the patient and the stent was removed from the body, removing all air.More air was noted during withdrawal.Another resolute integrity stent was then used.
Additional Manufacturer Narrative
The device was inspected before use with no issues noted.Negative prep/purging was performed on the device prior to use.Bubbles were noted coming up the syringe from the stent delivery system.The stent was removed from the body when the air bubbles were noticed.Stent was not deployed.The lesion was pre-dilated.No resistance was noted while advancing the device to the lesion.The device did not pass through a previously-deployed stent.No inflation pressure was applied prior to the leak.Contrast leak was not noted under fluoroscopy.It was reported that there was no embolism.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: 8653562
• Report Number: 9612164-2019-02094
• Device Sequence Number: 14021988
• Product Code: NIQ
• UDI-Device Identifier: 00643169037281
• UDI-Public: 00643169037281
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/01/2019

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: 09/30/2019
• Device Catalogue Number: RSINT35034UX
• Device Lot Number: 0008813097
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 05/30/2019
• Supplement Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1