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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT II BIFURCATED STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR

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MEDTRONIC IRELAND ENDURANT II BIFURCATED STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR Back to Search Results
Model Number ETBF3220C166EE
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2023
Event Type  malfunction  
Event Description
An endurant ii stent graft was intended to be implanted in a patient for the endovascular treatment of a 47mm abdominal aortic aneurysm.The proximal aortic neck diameter measured 28mm and 25mm in length with a 10 degree neck angulation.Low vessel calcification and tortuosity were noted.It was reported during the index procedure, the physician pushed the bifurcate graft proximal in the patients aorta and detected something in the x - ray which seemed to be inside of the contralateral limb.The physician removed the delivery system but was unable to see anything and decided not to use this main body.An additional endurant ii bifurcate (esbf3214c103ee) and endurant ii limb (etlw1620c124ee) were implanted and the procedure successfully completed with no adverse effects to the patient.After the operation, the physician released the stent (etbf3220c166ee (b)(4)) outside of the patient.Inside the contralateral limb the lower part of the tip capture system, the spindle was found.Per the physician the cause of the spindle detachment is undetermined.No additional clinical sequelae were reported and the patient is fine.
 
Manufacturer Narrative
Device evaluation summary: a series of six (6) images were received from the account.The images show graft prior to deployment.Two images show the spindle still attached to the spiral member post deployment of the graft.The loading hook is visible following removal from the graft contralateral limb post deployment.The reported foreign material was confirmed through image review.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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
Film evaluation summary: the reported event was confirmed on the film provided; however, the type of the radiopaque structure observed was most likely a loading hook.The cause of the event could not be determined.Device evaluation summary: a series of six (6) images were received from the account.The images show graft prior to deployment.Two images show the spindle still attached to the spiral member post deployment of the graft.The loading hook is visible following removal from the graft contralateral limb post deployment.The reported foreign material was confirmed through image review.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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 Name
ENDURANT II BIFURCATED STENT GRAFT
Type of Device
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI 
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
EI  
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key16774694
MDR Text Key313641785
Report Number9612164-2023-01675
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P100021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/23/2023
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
Device Operator Health Professional
Device Model NumberETBF3220C166EE
Device Catalogue NumberETBF3220C166EE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/06/2023
Initial Date FDA Received04/20/2023
Supplement Dates Manufacturer Received05/05/2023
Supplement Dates FDA Received05/23/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/05/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age66 YR
Patient SexMale
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