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

Model Number	ETLW1624C156E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	02/21/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Concomitant medical products: etlw1624c124e, sn (b)(4), expiration date: 2018-11-17, udi # (b)(4).Film evaluation summary: the cause of the proximal type i endoleak occurring at implant could not be determined from pre-implant films returned.Films during and post-implant were not available for return, and the in-vivo stent graft configuration could not be assessed.Pre-implant ct¿s revealed that the patient had a proximal neck that was moderately angulated ~55° maximum.The neck diameter ranged from 22 ¿ 25mm along the 3cm neck length which was also extensively calcified.It is possible that the angulated and calcified proximal neck may have contributed to the observed proximal type i endoleak.The cause of patient¿s death occurring after hospital discharge could not be determined from the information provided.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant iis stent graft system was implanted in the patient for the endovascular treatment of a 62 mm in diameter abdominal aortic aneurysm.It was reported that, during the index procedure, an angiogram revealed that the endurant iis stent graft bifurcate had a proximal type i endoleak.It was determined that the endurant iis stent graft bifurcate had been accurately implanted distal to the renal artery.The physician modeled the proximal end of the stent graft bifurcate with a balloon.However, after repeated ballooning, the proximal type i endoleak did not resolve.The physician then elected to implant seven aptus endoanchors since there was insufficient space between the renal arteries and the flow divider to place an aortic cuff.However, the proximal type i endoleak did not improve after the aptus endoanchors had been implanted.Due to the amount contrast used, the physician elected to complete the procedure.Per the physician, the cause of the event was unknown.The patient was released from the hospital and it was later reported that the patient expired in a nursing home.The physician stated that the patient cause of death was unknown and an autopsy was re fused.No additional clinical sequelae were reported.
Additional Manufacturer Narrative
Film evaluation summary: the cause of the proximal type i endoleak occurring at implant could not be determined from films returned.No stent graft issues were observed from the films provided.Previously returned pre-implant ct¿s revealed that the patient had a proximal neck that was moderately angulated and calcified.Angio images during implant confirmed an angulated neck which measured ~70°.After implanting the stent grafts and post-ballooning within the entire stent graft system, several still images showed that multiple endoanchors were seen having been implanted within the proximal bifurcate/aorta.No contrast angio injections were observed prior to or after implanting the anchors, and lack of contrast did not allow for assessment of any endoleak and stent graft/vessel patency.It is possible that the angulated and calcified proximal neck may have contributed to the observed proximal type i endoleak.The cause of patient¿s death occurring after hospital discharge could not be determined from the information provided.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.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.

• 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: 6415210
• Report Number: 2953200-2017-00413
• Device Sequence Number: 13460303
• Product Code: MIH
• UDI-Device Identifier: 00643169467491
• UDI-Public: 00643169467491
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup,Followup,Followup
• Report Date (Section B): 06/02/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2018
• Device Model Number: ETLW1624C156E
• Device Catalogue Number: ETLW1624C156E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Initial Date Received by Manufacturer: 02/21/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided; 06/02/2017
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 04/10/2017; 05/04/2017; 06/09/2017; 10/02/2017
• 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: Death
• Patient Age: 88 YR
• Patient Weight: 58