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

Model Number ETTF2323C70E

Device Problem Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant tube stent graft was implanted in the patient for the endovascular treatment of a 30mm saccular abdominal aortic aneurysm and penetrating atherosclerotic ulcer.It was reported, during the index procedure, that the physician decided to use an aortic extension graft tube only to exclude the aneurysm in the mid abdominal aorta.The graft was inserted into the patient via the right femoral artery using a cutdown approach and deployed at the level of the lowest accessory renal artery.The stent graft landed just above the aortic bifurcation.It was then reported that the physician re-captured the delivery system and removed it from the patient.Ballooning was performed using a reliant balloon and an angiogram was taken where no leaks were noted, and all vessels appeared to be intact, it was observed however, it did appear like the graft was not opposing the wall on the right side of the aorta.Further investigation showed that the stent graft appeared to be pushing up on itself along the posterior wall.The physician noted that the distal edge of the aneurysm was very close to the area with the stent graft pushing up on itself and the ct showed heavy plaque which might have caused the graft to catch on it.The graft was re-ballooned, and a tour guide sheath was used in an attempt to catch the stent graft and pull it back into its intended position.The physician commented that the patient had good blood flow throughout and the procedure was completed.Per the physician the cause of the event cannot be determined.No clinical sequalae were reported and the patient will be monitored.

Manufacturer Narrative

Film evaluation summary: from the films provided the exact cause of the mal-deployed distal stent and potential infolding could not be determined from the films provided.Pre-implant ct¿s revealed that the patient had a 26mm max diameter x 22mm length saccular aaa located ~55mm below the renal arteries.The infrarenal aorta was essentially straight.The distal aortic seal diameter ranged from 17 ¿ 18mm along a 3cm length and there was a significant area of calcification observed on the posterior aortic wall immediately below the aaa which reduced the flow lumen diameter to ~14 x 16mm.Two (2) still non-contrast films during implant revealed that the distal end of the stent graft (and associated graft marker bands) appeared to have been implanted mal-deployed and may have infolded; the distal marker on the patient¿s left side was 15 ¿ 20mm below/distal to the distal marker on the right side.Images during stent graft deployment and removal of the delivery system were not available, and post-ct¿s were also not provided to help assess the stent graft cross-section and lumen patency.It is possible that implanting the distal end of the stent graft within a location of notable calcification and resulting lumen narrowing, may have led to the observed mal-deployment and possible stent graft infolding.Since the films were non-contrast with no observed scale, no assessment of any endoleak, aneurysm exclusion, or stent graft patency could be performed, and no stent graft or vessel measurements could be performed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation summary: slight bending was evident to the tip.There was no evidence of scratches or damage caused by calcification observed on the tip.No abnormalities were noted retracting and advancing the graft cover and tip capture.There was no further damage noted to the delivery system.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II EXTENSION STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7327157
• MDR Text Key: 102082357
• Report Number: 2953200-2018-00349
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00613994991478
• UDI-Public: 00613994991478
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2019
• Device Model Number: ETTF2323C70E
• Device Catalogue Number: ETTF2323C70E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 03/09/2018
• Supplement Dates Manufacturer Received: 03/15/2018; 06/21/2018; 08/08/2018
• Supplement Dates FDA Received: 04/11/2018; 07/11/2018; 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR