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

Model Number	ETLW1610C156E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/19/2019
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 a 75mm abdominal aortic aneurysm.It was reported that during the index procedure, the physician extended into the right iliac limb with and endurant limb and ballooned the area.Contrast injection was injected and it showed a significant blush filling the right common and internal iliac arteries.As per the physician, the cause of the event is a type iiib endoleak due to a hole in the stent graft fabric from calcium in the right common iliac artery.The physician did not believe it was a type ib endoleak.Intervention was performed with the implantation of a 16x10x156 non mdt stent into the external iliac limb to resolve the endoleak.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Film analysis summary: the reported endoleak was confirmed; however, the exact source/cause of the endoleak could not be determined from videos returned.Pre-implant ct¿s were not provided; therefore, a comprehensive assessment of the patient¿s anatomy could not be performed.Additional films during implant, including stent graft deployment and ballooning, were also not available for review.Endoleak interrogation via selective angiograms (injecting from different levels within the stent graft) to help determine the source and rule out other potential endoleak sources was not seen, and only a single imaging view point (a-p) was observed in the films provided; thereby, making determination of the endoleak difficult.Analysis of the returned videos did not reveal any out of specification stent graft integrity issues.While a type iii fabric endoleak cannot be ruled out, this appears most likely to have been an acute type iv blush endoleak caused by fabric porosity.Other factors such as heparin dose, outflow resistance, and volume of the aneurysm sac may have also contributed to this likely type iv 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: 8649129
• Report Number: 9612164-2019-02060
• Device Sequence Number: 11272469
• Product Code: MIH
• UDI-Device Identifier: 00643169467637
• UDI-Public: 00643169467637
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2019

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: 02/06/2021
• Device Model Number: ETLW1610C156E
• Device Catalogue Number: ETLW1610C156E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2019
• Initial Date Received by Manufacturer: 05/19/2019
• Supplement Date Received by Manufacturer: 06/04/2019; 08/16/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 06/27/2019; 09/09/2019
• 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: 72 YR
• Patient Weight: 70