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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDO ANCHOR SYSTEM - HELI-FX AAA; ENDOVASCULAR SUTURING SYSTEM
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MEDTRONIC IRELAND ENDO ANCHOR SYSTEM - HELI-FX AAA; ENDOVASCULAR SUTURING SYSTEM Back to Search Results
Model Number HG-16-62-28
Medical Device Problem Code Defective Device (2588)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/23/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
A heli-fx endoanchoring system was used prophylactically with a non mdt stent graft in an endovascular procedure.It was reported that during the index procedure, the physician said the guide catheter was taking in air between preloading and deploying the endoanchors.When the catheter guide was taken out of the applier, an air bubble was observed.The air was aspirated to resolve this.As per the physician the cause of the event was product related.No additional clinical sequelae were provided, and the patient is fine.
 
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Brand Name
ENDO ANCHOR SYSTEM - HELI-FX AAA
Common Device Name
ENDOVASCULAR SUTURING SYSTEM
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
IE 
MDR Report Key10641028
Report Number9612164-2020-03797
Device Sequence Number19745075
Product Code OTD
UDI-Device Identifier00763000225971
UDI-Public00763000225971
Combination Product (Y/N)N
Initial Reporter CountryFI
PMA/510(K) Number
K140036
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date02/23/2022
Device Model NumberHG-16-62-28
Device Catalogue NumberHG-16-62-28
Device Lot Number0010148943
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/23/2020
Initial Report FDA Received Date10/07/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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