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

Model Number	ETTF3232C70E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Death (1802)
Date of Event	05/24/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Concomitant products: etcf3232c49e sn (b)(4), expiration date: 2018-01-21, (b)(4).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 ii stent graft system was implanted in a patient for the endovascular treatment for another manufacturer¿s displaced distal, migrated, and the proximal stent crown appeared to have perforated the aorta and aneurysm ruptured abdominal aortic aneurysm.It was reported that during the intervention the angiogram demonstrated extravasation in the infra renal aortic neck.The physician elected to implant an endurant aortic cuff at the renal arteries in the standard manner.Post dilatation of the endurant stent graft was done with another manufacturer¿s balloon.Angiography demonstrated a persistent type ia endoleak/extravasation.Another endurant aortic cuff was implanted in the standard manner with post ballooning.The proximal type i endoleak persisted.The physician implanted seven heli-fx endoanchors in the standard manner in the infrarenal aortic neck.Angiography demonstrated resolution of the proximal type i endoleak.It was reported that during the removal of the sheathes the patient experience cardiac arrest.Efforts to resuscitate the patient were initiated, however the patient was pronounced deceased after several minutes.Per the physician, the causes of the events were related to the patient¿s anatomy and another manufacturer¿s stent graft failure.No additional clinical sequelae were reported.
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.
Event or Problem Description
Additional information received.The patient experienced cardiac arrest during removal of the vascular access sheaths that had been placed in the femoral arteries and were being removed upon final closure.
Additional Manufacturer Narrative
Off-label, unapproved or contraindicated use: neck angulation film evaluation summary: review of ct¿s revealed that another manufacturer¿s aaa stent graft system had been implanted in the patient.There appeared to be lack of a proximal seal.The bifurcate was ~2cm below the left renal, and was positioned within the top of the aaa sac which measured ~9cm in diameter and appeared to have ruptured.The proximal bifurcate and infrarenal neck were angulated ~90 deg lt-rt relative to the distal aorta, and the suprarenal neck was angulated ~50 deg.There appeared to be adequate distal limb sealing within the common iliacs bilaterally.Review of angio images during an intervention showed an aortic perforation or rupture near the top of the aaa; ~5cm distal to the renal arteries.The bifurcate was acutely angulated 90 deg lt-rt at its mid-length.From the right side, an endurant aortic tube was brought up and deployed just below the renal arteries.The aortic perforation/rupture did not appear to have been excluded.The cuff proximal od measured ~32mm and the aortic diameter at the level of the suprarenal stents measured 23mm.The suprarenal stents were deployed within the acutely angulated suprarenal neck; which measured 50 deg rt-lt.The cuff was then seen ballooned; however the endoleak persisted.An additional cuff was implanted near the level of the 1st tube, and after ballooning the perforation still persisted along the inner curvature.No other stent graft issues were observed.Multiple endoanchors were then seen implanted into the cuff¿s/aorta, and angio injection showed likely resolution of the previously seen aortic perforation/rupture.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 EXTENSION STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6644428
• Report Number: 2953200-2017-00987
• Device Sequence Number: 979042
• Product Code: MIH
• UDI-Device Identifier: 00613994991508
• UDI-Public: 00613994991508
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 07/11/2017

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: 10/11/2018
• Device Model Number: ETTF3232C70E
• Device Catalogue Number: ETTF3232C70E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: 06/19/2017; 07/11/2017; 07/11/2017
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 07/10/2017; 08/03/2017; 10/04/2017
• 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; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 110