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

Catalog Number	RSINT22530UX
Medical Device Problem Codes	Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The stent was moved partially distally on the balloon.Crimp impressions were visible on the exposed proximal balloon surface.Deformation was evident to the 23rd, 24th, 25th and 26th distal stent wraps with struts raised.The balloon had not been inflated.The distal shaft was torn starting from the guidewire entry port and extending 2.6cm distally through the inner and outer lumen.The inner and outer lumen material was jagged and uneven at the tear site.The distal shaft was kinked 12.7cm distal to the guidewire entry port.Slight deformation was evident to the distal tip.Resistance was felt loading 0.015 inch mandrel through the inner lumen.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 implant the resolute integrity rx stent in a patient's mid circumflex (cx) artery which had moderate tortuosity, calcification and 80% stenosis.No reported damage to packaging and no issues noted when removing device from hoop/tray.The device was inspected with no issues.Negative prep was not performed during prep.It was reported that during the procedure, negative pressure was pulled right before inflation, when the device was positioned at the lesion, and blood was noticed in the saline mixture (balloon leak).The device did not pass through a previously deployed stent nor was resistance encountered when advancing the device.Device was never implanted.No patient injury reported.The procedure was completed using a resolute 2.25 x 30mm rx stent.

• 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: 6661056
• Report Number: 9612164-2017-00796
• Device Sequence Number: 1967764
• Product Code: NIQ
• UDI-Device Identifier: 00643169037335
• UDI-Public: 00643169037335
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2017

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: 03/08/2019
• Device Catalogue Number: RSINT22530UX
• Device Lot Number: 0008527392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2017
• Initial Report FDA Received Date: 06/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1