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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
Model Number RSINT25018UX
Device Problems Difficult To Position; Material Deformation
Event Date 08/08/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the physician was attempting to use a resolute integrity rx drug eluting stent. Lesion was calcific. No issues were noted when removing the device from the hoop/tray. The device was inspected and negative prep performed with no issues noted. During the procedure, it was reported that stent deformation in vivo during positioning occurred. Physician attempted to cross the lesion several times without success. On removal, damage was noted to the device. There was a tear in the side of the stent and struts were sticking out. The physician completed the procedure. No patient injury reported.

 
Manufacturer Narrative

Additional information received: the device was used to treat a moderately calcified and tortuous mid lad lesion. No damage was noted to the device packaging. The lesion was pre-dilated. During the procedure, the stent did pass through a previously deployed stent. Resistance was noted when advancing the stent and excessive force used. The stent caught on a previously implanted stent and pulled the strut out. The stent was replaced with a smaller resolute. 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.

 
Manufacturer Narrative

Device evaluation: kinks were visible on the hypotube and distal shaft of the returned device. The stent was positioned on the balloon between the marker bands as per specifications. Deformation was visible to the 4th, 5th, 6th and 7th distal stent wraps with raised a bunched struts. Crimp impressions were visible on the exposed balloon surface. The most proximal stent wrap was slightly expanded. There was damage 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 Key5924447
Report Number9612164-2016-00933
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/13/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/02/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/05/2017
Device MODEL NumberRSINT25018UX
Device Catalogue NumberRSINT25018UX
Device LOT Number0007774683
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/24/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/06/2015
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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