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

Model Number	ETBF2513C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the endoleak seen during implant could not be determined from the limited still films provided.Pre-implant ct¿s were not provided.However, a pre-implant film report noted that the proximal neck diameter just below the lowest right renal measured 20mm, and ranged from 21 ¿ 25mm along the 23mm neck length.The neck was extensively calcified and moderately angulated.Angio injection from above the renals showed contrast within the top of the aaa sac from a possible proximal type i endoleak.The final angiogram showed that an aortic cuff was implanted ~5mm above the bifurcate, and multiple (10 ¿ 15) endoanchors had been implanted into the bifurcate/cuff/aorta.The level of contrast seen within the proximal sac appeared to have been reduced; however, a possible type ia was present.It is possible that implanting within the calcified and reverse-tapered neck may have contributed the reported type ia endoleak.It is also possible that this may have been a type iv caused by fabric porosity.The films returned were still images, no endoleak interrogation (injecting from different levels within the stent graft) to help determine the source and rule out other endoleak sources was seen, and only a single imaging view point (a-p) was observed in the films provided; thereby, making determination of the endoleak difficult.Factors such as heparin dose, outflow resistance, and volume of the aneurysm sac may have also contributed to a potential type iv endoleak.
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 58mm diameter abdominal aortic aneurysm.The infrarenal neck was 23mm in length, 19.8 - 21.2mm in diameter at 10mm below the renal arteries and 22.5mm at 20mm below the renal arteries.It was reported that the stent graft was implanted without issue.The final angiogram was performed indicating a type ia endoleak.An endurant cuff and heli-fx endoanchors were implanted.The endoleak improved but did not completely resolve.The procedure time was over 4hrs and contrast used in the procedure was high.The physician elected to wait 30 days and see what the ct shows.No further intervention was performed.The ct showed eccentric calcium deposits within the infrarenal target area; however, per the physician the cause of the event is cannot be determined.No additional clinical sequelae were reported and the patient will be monitored by their physician.
Additional Manufacturer Narrative
Additional information received reported that a follow up ct was carried out.Per the physician the ct showed that the aneurysm had been excluded without any leaks remaining.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: 6907613
• Report Number: 2953200-2017-01542
• Device Sequence Number: 19055373
• Product Code: MIH
• UDI-Device Identifier: 00613994991249
• UDI-Public: 00613994991249
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2017

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: 06/16/2019
• Device Model Number: ETBF2513C166E
• Device Catalogue Number: ETBF2513C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Initial Date Received by Manufacturer: 09/11/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 11/01/2017
• 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: 78 YR