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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELANDRESOLUTE INTEGRITY RX CORONARY STENT SYSTEM

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MEDTRONIC IRELAND RESOLUTE INTEGRITY RX CORONARY STENT SYSTEM   Back to Search Results
Catalog Number RSINT30038X
Device Problem Material deformation
Event Date 05/28/2011
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Evaluation: results - (patient vessel/lesion morphology; tortuosity of the vessel has prevented the device from advancing to the lesion), (stent deformation and failure to deliver device). Conclusion - (patient vessel/lesion morphology; tortuosity of the vessel has prevented the device from advancing to the lesion). Evaluation summary: the seventeenth and eighteenth proximal stent segments were raised, damaged and deformed. The twenty third and twenty fourth proximal stent segments were raised and deformed. A number of other segments were slightly raised and deformed. The stent was positioned on the balloon between the marker bands as per specs. The inflation lumen was kinked. Please note that this device (b)(4) is distributed outside the united states; however, it is similar to the united states distributed product (b)(4).

 
Event Description

The physician was attempting to deploy a 3. 0 mm diameter x 38mm length resolute integrity rapid exchange (rx) drug eluting stent to treat a lesion located in the lcx that exhibited moderate tortuosity, little calcification and 80% stenosis. It was reported that prior to use, the device was inspected and prepped with no issues noted. It was also reported that the lesion was pre-dilated twice with less than 50% stenosis remaining. Resistance was felt while advancing the resolute integrity stent inside the vessel towards the lesion and upon removal from the pt, the stent was reported to be damaged. No pt injury occurred and no clinical sequelae were reported.

 
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Brand NameRESOLUTE INTEGRITY RX CORONARY STENT SYSTEM
Manufacturer (Section F)
MEDTRONIC IRELAND
parkmore business park west
galway
IRELAND
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
IRELAND
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
IRELAND
Manufacturer Contact
ludmilla voulfson
3576 unocal place
santa rosa , CA 95403
(707) 566 -1229
Device Event Key2253130
MDR Report Key2186857
Event Key2083792
Report Number9612164-2011-00762
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/18/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/15/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date03/28/2013
Device Catalogue NumberRSINT30038X
Device LOT Number0005622412
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer07/04/2011
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received06/18/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/29/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/15/2011 Patient Sequence Number: 1
#TreatmentTreatment Date
UNK
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