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

Model Number	RSINT30022UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2019
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
During the procedure an attempt was made to use one resolute integrity rx coronary drug eluting stent to treat a severely calcified lesion in the obtuse marginal (om).There were no issues removing the device from the hoop.It was reported that the stent frayed while attempting to cross the lesion.The device was removed from the patient.No patient injury was reported.
Additional Manufacturer Narrative
The device was inspected with no issues noted.The device did not pass through a previously deployed stent.Several attempts were made to cross the lesion without success.Excessive force was not noted.No part of the device detached in two.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 11th and 12th distal stent wraps with struts raised.Deformation was evident to the distal tip.The inner lumen could not be verified with a 0.015 inch mandrel most likely due to hardened blood in the guide wire lumen.Slight bends are evident on the shaft of the device which are consistent with coiling of the device for return.No other damage evident to the remainder of the device.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: 8256250
• Report Number: 9612164-2019-00213
• Device Sequence Number: 1866795
• Product Code: NIQ
• UDI-Device Identifier: 00643169037168
• UDI-Public: 00643169037168
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2019

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: 05/23/2020
• Device Model Number: RSINT30022UX
• Device Catalogue Number: RSINT30022UX
• Device Lot Number: 0009157487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 01/21/2019; 03/13/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 02/19/2019; 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1