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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING Back to Search Results
Catalog Number RSINT27518UX
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

An attempt was being made to use a resolute integrity drug eluting stent in a heavily calcified lad lesion. The device was inspected before use and no issues were reported. The lesion was pre-dilated. Resistance was not noted while getting to the lesion and excessive force was not used. When advancement became a little harder the device was retracted. Stent deformation was then noticed. The procedure was completed using another stent. No patient injury reported.

 
Manufacturer Narrative

Review of cine images received: the images capture calcified lesion sites in the lad as reported by the account. Pre-dilation is visible from the images by an unidentified balloon. There are no images capturing the attempted delivery and subsequent removal of the resolute integrity 2. 75 x 18mm device. The images show the delivery and successful deployment of numerous unidentified stents along the length of the vessel. Product analysis: the stent delivery system was returned to medtronic for evaluation. On review the stent was positioned on the balloon between the marker bands as per specifications. There was deformation to the first distal stent wrap with struts raised. There were kinks along the distal shaft 9. 2cm and 21. 4cm distal to the guidewire entry port. There was deformation to the distal tip. 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.

 
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Brand NameRESOLUTE INTEGRITY RX
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key6188377
MDR Text Key62791195
Report Number9612164-2016-01330
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP110013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/07/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/20/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/12/2018
Device Catalogue NumberRSINT27518UX
Device LOT Number0008052334
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/18/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/12/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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