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

Model Number	ETBF2313C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/27/2018
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.The neck length was 16mm with diameters of 19-20 mm.It was reported that after implantation, after ballooning the neck and limbs, a type ia endoleak was noted on the completion angiogram.The neck was re-ballooned for a prolonged period and another endurant stent graft was implanted on the same day.After further treatment the leak was diminished on the angiogram, but still present.As per the physician, the cause of the event was anatomy related, due to a short neck.No additional clinical sequelae were reported and the patient will be monitored by their physician.
Additional Manufacturer Narrative
Film evaluation summary the exact cause of the proximal type ia endoleak during implant could not be determined from the pre-implant film report provided.Complete pre-implant ct¿s were not available, films during implant were not provided and the reported event could not be assessed, and post-implant films were also not available for return.Review of a returned pre-implant ct/3d film report revealed that the proximal neck measured 19mm in diameter, 16mm in length, calcified, and the infrarenal neck was severely angulated measuring ~75 deg relative to the distal aorta.The distal aorta was tight and calcified, ranging in diameter from 16 ¿ 10 ¿ 13mm, and the common iliacs were non-tortuous and calcified; bilaterally.It is possible that the patient¿s challenging neck anatomy may have been a primary contributor to the observed proximal type i endoleak.Additional information received; it was reported that only one endurant device was implanted in the patient, no additional stent graft was implanted to treat the type ia endoleak during the index procedure.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional info it was reported that the patient's one month follow up ct showed no type i endoleak.No additional clinical sequelae were reported and the patient is fine.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: 8114565
• Report Number: 2953200-2018-01634
• Device Sequence Number: 16210200
• Product Code: MIH
• UDI-Device Identifier: 00613994991188
• UDI-Public: 00613994991188
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2019

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: 09/26/2020
• Device Model Number: ETBF2313C166E
• Device Catalogue Number: ETBF2313C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 11/28/2018; 12/28/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 12/18/2018; 01/16/2019
• 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: 73 YR