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

Catalog Number	RSINT30018UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2018
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 drug eluting stent to treat a moderately tortuous and moderately calcified lesion with 80% stenosis located in the proximal lad.There was no damage noted to the device packaging.There were no issues removing the device from the hoop.The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that the stent failed to cross the lesion and when taken out to use a guide liner the stent was noted to be deformed.Another resolute integrity of the same size was then used.Patient status is alive with no injury.
Additional Manufacturer Narrative
Evaluation summary: kinks were evident on the hypotube from 52cm to 132cm proximal to the distal tip.The stent was positioned on the balloon between the marker bands but not meeting spec due to the deformation of stent struts.Deformation was evident to the 18th distal stent wraps with struts raised and stretched.Deformation was evident to the distal tip.The inner 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: 7599984
• Report Number: 9612164-2018-01445
• Device Sequence Number: 1623288
• Product Code: NIQ
• UDI-Device Identifier: 00643169037151
• UDI-Public: 00643169037151
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/27/2018

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: 09/04/2019
• Device Catalogue Number: RSINT30018UX
• Device Lot Number: 0008782074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2018
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1