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

Model Number	ETBF3616C166E
Medical Device Problem Codes	Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: a secondary intervention procedure took place approximately one week post follow up and a large non-mdt stent was implanted in the proximal portion of the main body.It was reported that this appeared to successfully address the infold as there was no endoleak noted at the end of the procedure.Film analysis: the reported infolding of the bifurcate leading to the proximal type i endoleak was confirmed.The exact cause could not be determined; however, it is likely that stent graft oversizing may have contributed.Implanting a 36mm bifurcate into a 27 ¿ 29mm proximal neck, which contained irregular-shaped thrombus further reducing the flow lumen to ~21mm as well as calcification.The infolding may have occurred during implant.However, images during implant were not available for review so the timing of the infolding could be confirmed.If information is provided in the future, a supplemental report will be issued.
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 55m abdominal aortic aneurysm.It was reported that the index procedure was completed without any obvious clinical issues.However, follow up ct three months later showed a type ia endoleak from a large infold in the straight tube portion of the main stent graft body.As per the physician, the cause of the event was due to an oversized stent graft.No additional clinical sequelae were reported and the patient is being monitored.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9615559
• Report Number: 9612164-2020-00376
• Device Sequence Number: 11443499
• Product Code: MIH
• UDI-Device Identifier: 00613994991041
• UDI-Public: 00613994991041
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 02/18/2020

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 Date: 08/11/2021
• Device Model Number: ETBF3616C166E
• Device Catalogue Number: ETBF3616C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2020
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 02/18/2020
• 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: 67 YR