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

Catalog Number ETUF2514C102EE

Device Problems Separation Failure (2547); Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)

Patient Problems Death (1802); Injury (2348)

Event Date 04/30/2014

Event Type  Death  

Event Description

An endurant ii stent graft system was implanted for the endovascular treatment of an abdominal aortic aneurysm.Vessel morphology is unknown, but it is reported that there was no significant angulation or tortuosity.It was reported that the patient presented emergently with a ruptured aneurysm.The physician attempted to implant the stent graft, and all went well until the time came to release the anchoring pins.The tip of the suprarenal stent was released, and imaging revealed that one of the anchoring pins was not completely released.The physician moved the delivery system around in an attempt to release the pin, and in the process moved the stent graft out of the desired position.The physician was unable to get the tip to release, even after using the recommended troubleshooting methods, and decided to convert to open surgery.The delivery system was cut into two pieces, with the distal portion removed through the femoral artery, and the remaining portion through the opened aorta.The patient died 72 hours later due to complications in icu.The patient had originally been rejected for open surgery.The physician commented that it was a ruptured aneurysm, and the patient had few chances to survive.A review of several returned still cta's showed that the neck was highly angulated (greater than 60 deg).The neck and iliacs were severely calcified.Images at implant were not provided.It is possible that the angulated and calcified neck may have contributed to the anchoring pin not completely releasing.

Manufacturer Narrative

(b)(4).Neck angulation > 60 degrees, pre-operative rupture.

Manufacturer Narrative

The stent graft was removed during surgical conversion, immediately following the attempted implant, due to suprarenal stent deployment difficulties and delivery system removal difficulties.The patient was being treated for a ruptured aaa and was not a candidate for open surgery.During implant of the aui, imaging revealed that one of the suprarenal stents had not completely released.The physician moved the delivery system around in an attempt to release the stent, and in the process moved the stent graft out of the desired position.After using the recommended troubleshooting methods, the physician was unable to get the suprarenal stent to release or remove the delivery system, and the decision was made to convert the patient to open surgery.During the open repair the delivery system was cut into two pieces; the distal portion was removed through the femoral artery and the remaining portion through the opened aorta.The stent graft was explanted and the patient was converted; however, the patient died 72 hours later due to complications in the icu.From the examination of the returned devices and the limited clinical information provided, the cause of the implantation difficulties could not be determined.The stent graft was returned with the proximal 4cm¿s (4 covered stents) of the stent graft fabric and the suprarenal stents infolded into the distal 6cm length portion of the stent graft.After pulling the inverted section out of the distal section, 2 of the suprarenal stents were found entangled, and 2 other suprarenal stents were observed to be severely bent.The distal suture attachment between these two severely bent stents was cut and had detached from the proximal graft margin.The findings were likely caused during the attempts to release the stuck suprarenal stent and remove the delivery system.No other device integrity issues were seen, and the endurant aui was confirmed to have met all manufacturing specifications prior to shipment.The tapered tip of the delivery system was also returned with severe damage which likely occurred during the attempts to free the entangled suprarenal stents and remove the delivery system.There was additional damage seen likely caused by hemostats during the open repair.The remaining portion of the delivery system was not returned, thereby limiting the extent of the delivery system evaluation.Details of the patient¿s anatomy at implant and films during the implant procedure were not provided.A review of several returned still cta's prior to implant (unknown study date) showed that the proximal neck was highly angulated; appeared greater than 60º.The proximal neck and iliac arteries were also severely calcified.It is possible that the angulated and calcified neck may have contributed to the suprarenal stent not completely releasing and the delivery system removal difficulties.

Manufacturer Narrative

Corrected information: no eval explain code.

• Brand Name: ENDURANT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: ludmila voulfson ; 3576 unocal place; santa rosa, CA 95403 ; 7075661229
• MDR Report Key: 3841480
• MDR Text Key: 4410925
• Report Number: 2953200-2014-01091
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2015
• Device Catalogue Number: ETUF2514C102EE
• Device Lot Number: V04151392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2013
• 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 Outcome(s): Death