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

Catalog Number	RSINT30022UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2018
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
An attempt was made to use a resolute integrity drug eluting stent to treat a moderately tortuous, mildly calcified lesion with 80% stenosis in the mid saphenous vein graft (svg).There was no damage noted to the device packaging.There were no issues removing the device from the hoop.The device was inspected and negative prep was performed with no issues.The lesion was pre-dilated.The device passed through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used.It is reported that the stent had difficulty advancing through a previously deployed stent to the lesion site.The physician then removed the stent and noted that the struts had flared during advancement.A rsint30018ux device was used to successfully complete the procedure.No patient injury is reported.
Additional Manufacturer Narrative
Evaluation summary: the device returned with a kink evident on the hypotube, 15.9cms proximal to the guidewire entry point.The stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 14th stent wrap with struts raised.No deformation was evident to the distal tip.The guidewire lumen patency was not verified with a 0.015 inch mandrel due to hardened blood.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7450042
• Report Number: 9612164-2018-00838
• Device Sequence Number: 18858480
• Product Code: NIQ
• UDI-Device Identifier: 00643169037168
• UDI-Public: 00643169037168
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 10/04/2018

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: 05/15/2019
• Device Catalogue Number: RSINT30022UX
• Device Lot Number: 0008632591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 07/06/2018; 08/08/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 08/01/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1