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

Model Number	ETLW1628C93E
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm of unknown size.It was reported that approximately 5 years post implant, ct was performed which showed a type ib endoleak in the right common iliac due to retraction of the endurant limb.The patient was successfully treated 10 days later with a limb extension.As per the physician, the cause of the event was related to disease progression in the right common iliac.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Film evaluation summary: the reported retraction of the right limb extension out of the right common iliac artery, leading to the type ib distal endoleak was confirmed.The exact cause of the migration could not be determined; however, this appears most likely to have been anatomy related due to disease progression (iliac artery dilatation) with possible morphology changes.The anatomy at implant is unknown and earlier post-implant films were not provided for comparison.It is also possible that the resulting acute stent graft angulation within the aaa sac may have led to the observed thrombus seen within the right limb and bifurcate aortic body.There appeared to be marginal component overlap between the ipsi and right limb extension, which most likely was a result of the limb migration.Although a type iiia endoleak could not be confirmed from the returned ct¿s, it is possible that there was associated sac pressurization from this marginal junction which may have also contributed to aaa expansion along with the distal type i endoleak.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8645191
• Report Number: 9612164-2019-02019
• Device Sequence Number: 13934271
• Product Code: MIH
• UDI-Device Identifier: 00613994991331
• UDI-Public: 00613994991331
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2014
• Device Model Number: ETLW1628C93E
• Device Catalogue Number: ETLW1628C93E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 06/03/2019; 07/15/2019
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 06/27/2019; 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR