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

Catalog Number ETBF3616C145E

Device Problems Leak/Splash (1354); Separation Failure (2547); Folded (2630)

Patient Problem Injury (2348)

Event Date 12/06/2014

Event Type  Injury  

Event Description

An endurant ii stent graft system was implanted for treatment of an abdominal aortic aneurysm.Proximal neck measure 29, 30, 32, and 33 and was about 15mm in length.It was reported that the patient presented emergently with abdominal pain and a ruptured aneurysm.After the stent grafts were implanted, on final angiogram a type i endoleak was noted.Re-ballooned with the coda balloon, while the type i endoleak looked better, it was still apparent.However, the physician decided to leave it.The patient went to pacu and was still complaining of pain.A ct was completed and analyzed to identify a pleat in the graft from the very top of the fabric distally causing the type i endoleak.Upon further analysis using tera recon, the physician could see the two right posterior supra renal stents were intertwined.The physician brought the patient back into the or with a plan to figure out exactly what was going on and determine a plan of action.Using ivus, he could see the pleat from the top of the fabric was about 35mm in length landing about 15mm above the flow divider.The physician tried to use a balloon first and manipulate the joined sr stents using that balloon.That was unsuccessful.The next step was to aptus staples at the right posterior quadrant using 17 aptus staples.While the leak appeared better, is was not resolved.A 10/50 palmaz stent was mounted on a 30mm balloon and deployed successfully.The palmaz was then ballooned to fully expand it to the 36mm diameter of the graft.The final angiogram still showed a leak.The patient tolerated the procedure.The patient still had quite a palpable aortic pulse and was symptomatic coming in to yesterday's follow up case.The following day another ct was done noting that the type i endoleak has shrunk, the pain has gone away for the most part and the patient was discharged.The physician is monitoring the patient.No additional clinical sequelae were reported.A review of several returned films.Review of a 9 second video from a cta study (unknown date) showed that the aortic body appeared to have infolded.There was also a possible suprarenal stent entanglement; however, this was difficult to confirm since the video did not show the entire suprarenal stents.The ipsilateral limb was positioned within the right iliac, and the contra limb into the left iliac.There was a likely proximal type i endoleak.Another 18 second video during angiogram procedure (unknown study date) revealed that multiple aptus staples had been placed into the proximal 2cm¿s of the bifurcate along the right wall of the aorta.A palmaz stent was also visible within the aortic body extending to slightly above the proximal stent graft margin.An endoleak was seen; possibly a proximal type i.The proximal stent graft od measured approximately 22mm, and the aortic neck appeared relatively straight l-r.A single still cta 3d recon image showed that 2 adjacent suprarenal stents appeared to have entangled.The cause of the proximal type i endoleak was likely due to the suprarenal stent entanglement, which caused a section of the aortic body fabric to infold.Images during the implant procedure were not available for return.The cause of the entanglement could not be determined from these images.

Manufacturer Narrative

(b)(4).Evaluation, conclusions: off-label, unapproved, or contraindicated use (pre-operative rupture).

• Brand Name: ENDURANT II
• 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: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 4361703
• MDR Text Key: 21555930
• Report Number: 2953200-2014-02755
• Device Sequence Number: 1
• Product Code: MIH
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2016
• Device Catalogue Number: ETBF3616C145E
• Device Lot Number: V05906095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2014
• Initial Date FDA Received: 12/24/2014
• Date Device Manufactured: 08/13/2014
• 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): Required Intervention
• Patient Age: 00090 YR