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

Model Number	ETBF3216C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Film evaluation summary: the reported endoleak seen immediately following implant was confirmed; however, the exact cause/source of the endoleak could not be determined from the films returned.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy, and films during stent graft deployment and ballooning were also not available.Analysis of the returned videos did not reveal any out of specification stent graft integrity issues.A type ia endoleak seems unlikely as the contrast blush was also seen after pulling down the injector into the aortic body, and a type iiia junctional endoleak seems less likely as there appeared to be sufficient component overlap.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 which most likely would have self-resolved within 24 hours.Other factors such as heparin dose, outflow resistance, and volume of the aneurysm sac may have also contributed to this likely type iv endoleak.The likely endoleak source appeared to be in a location where the components were not overlapping; across a single fabric layer of the bifurcate between the bottom of the proximal neck and the flow divider.Other relevant device(s) are: product id: etlw1616c156e, serial/lot #: (b)(4), ubd: 01-may-2021, udi#: (b)(4); product id: etlw1616c124e, serial/lot #: (b)(4), ubd: 17-sep-2021, udi#: (b)(4).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 85mm diameter abdominal aortic aneurysm.The patient was noted to have good evar anatomy with a long neck and minor calcification.It was reported that during the index procedure upon completion angiogram, a large blush of contrast was noted below the neck.On repeat angiogram with the catheter pulled further into the stent graft to eliminate the potential of a type ia endoleak, the endoleak was noted again.The neck was re-ballooned and on further imaging with co2 as contrast to preserve kidney function, the endoleak was still present and peri-graft.After implantation of a cuff the endoleak was still present and after further implantation of additional stent grafts to reline the limbs the endoleak was mostly resolved but still present minimally.The procedure was completed.The patient had a follow-up ultrasound two days later which showed that the endoleak was still present.The cause of the endoleak noted was not provided as per the physician.The type of endoleak could not be conclusively determined.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
Additional pli added.Other relevant device(s) are: product id: etcf3232c49e, serial/lot #: (b)(4), ubd: (b)(4) 2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

• 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: 9391441
• Report Number: 9612164-2019-04948
• Device Sequence Number: 16571860
• Product Code: MIH
• UDI-Device Identifier: 00613994990983
• UDI-Public: 00613994990983
• 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): 12/02/2019

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: 04/22/2021
• Device Model Number: ETBF3216C145E
• Device Catalogue Number: ETBF3216C145E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 11/29/2019
• Supplement Report FDA Received Date: 12/02/2019
• 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