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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 RSINT25014UX
Device Problems Migration or Expulsion of Device (1395); Device Damaged by Another Device (2915)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/23/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician intended to a resolute integrity drug eluting stent to treat a lesion located in the proximal ramus. No damage was noted to packaging and no issues were noted when removing the device from the hoop/tray. The device was inspected with no issues. Resistance was not encountered when advancing the device and excessive force was not used during delivery. The device did not pass through a previously deployed stent. It was reported that the stent was deployed in proximal ramus without issue. After the ramus stent was placed the physician attempted to wire the circumflex artery. The non-medtronic coronary wire became stuck to proximal end of stent that was placed in the ramus. The physician stated he used a lot of force to try and remove the wire but each time he pulled, the guide catheter was being pulled into the ramus. The wire eventually pulled free and the physician was able to place the wire down the circumflex. While working on placing a stent into the circumflex they noticed the ramus stent was no longer in place. The stent was never found after looking under fluoroscopy and inspecting the guides and wires used. The product was replaced by another resolute integrity device of the same size. No intervention was reported. No patient injuries reported.
 
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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 Key7208854
MDR Text Key98013906
Report Number9612164-2018-00115
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRSINT25014UX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/26/2017
Was Device Evaluated by Manufacturer? No
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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