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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND MICRA INTRODUCER, CATHETER

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MEDTRONIC IRELAND MICRA INTRODUCER, CATHETER Back to Search Results
Model Number MI2355A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Thrombosis (2100); Thrombus (2101)
Event Date 05/20/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during the implant procedure of the leadless implantable pulse generator (ipg), a thrombus and hematoma occurred. The patient developed a deep vein thrombosis (dvt) which was attributed to a long procedure time. Anticoagulation medication was administered and subsequent doppler imaging evidenced resolution of the dvt. The hematoma was at the groin introducer site and did not require any medical intervention but resolved on its own. It was further reported that during the implant procedure, after placement of the ipg, the tether on the delivery system was cut and was unable to be removed. The delivery system could not be moved forward or backward despite several attempts and the delivery system was unable to retrieve the ipg. It was decided to remove the ipg and delivery system together. Upon removal, intracardiac tissue remnants were knotted up with the tether that were most likely part of tricuspid valve apparatus, part of chordae, and tissue of one of the leaflets. On subsequent echo evaluation, there was evidence of significant tricuspid regurgitation which did not have any significant clinical expressions on patient evaluation right after procedure or one month later and didn¿t require any surgical or medical intervention. A transvenous ipg system was implanted the following day. No further patient complications have been reported as a result of this event.
 
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Brand NameMICRA
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway,ie
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway,ie
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key9205609
MDR Text Key162999486
Report Number9612164-2019-04409
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K132030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMI2355A
Device Catalogue NumberMI2355A
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 Received05/20/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/17/2019 Patient Sequence Number: 1
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