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

Model Number ETLW1613C93EE

Device Problems Leak/Splash (1354); Patient-Device Incompatibility (2682)

Patient Problems Hemolysis (1886); Hyperbilirubinemia (1903); Reaction (2414)

Event Date 12/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

An endurant ii stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.Chimney procedure was performed.It was reported that during the index procedure, a type iii endoleak was identified was coming from the o verlap of the endurant ii 16x16x93 and the 16x13x93.An additional stent graft limb was implanted, resolving the endoleak.It was also reported that fourteen days after the index procedure, the patient was still in the icu due to a drop in red blood cells and jaundice (high bilirubin).The physician reviewed the implant films and it seems successful (no leaks, full patency in key vessels).Per the physician, the cause of the event is unknown however, the hypothesis being explored is the possibility of an autoimmune reaction to the fabric of the endurant ii stent graft.No additional clinical sequelae were reported and the patient is being monitored.

Event Description

Additional information received reported that the patient was sent home still with high limits of bilirubin.It was noted that the physician did not consider the endoleak to be present in the cts and did not think it was related to the changes in red blood cells and bilirubin.

Manufacturer Narrative

Film evaluation results are: a review of returned ct¿s from 3 days post-implant revealed that an endurant stent graft system was implanted in the patient.The bifurcate was positioned covering the sma and renal arteries; which were all chimney stented and appeared patent.The endurant suprarenal stent apices were deployed just anterior to the level of the celiac artery takeoff; the suprarenal flow lumen diameter measured ~25mm at this level.The proximal aspect of the 3 chimneys were all positioned outside the bifurcate along the anterior wall of the aorta, causing infolding of the bifurcate proximal margin.The origin of the celiac was also near these anterior stents; however, the celiac appeared patent.The aorta measured 27 x 23mm at this level.The proximal stent graft od measured ~27mm l-r and the aortic body was compressed down to ~7mm in the a-p orientation due to the implanted chimney¿s.Approximately 3cm distally, just below the takeoff of the lowest right renal artery chimney near the bottom of the neck, the bifurcate od expanded out to 30mm x 21mm.The max diameter aaa measured 7.4cm and no obvious endoleak was observed.Within the anterior of the mid-sac 3 likely air pockets were observed.The bubbles ranged in size from 4mm to 12mm in diameter.The bifurcate ipsi limb opened on the right side, and was extended with multiple endurant limbs into the right common iliac artery which was aneurysmal (~5.2cm diameter).Near the distal end of the endurant limb, two other manufacturer¿s stents were anastomosed, with one stent placed into the right internal iliac artery and the other stent was seen extended into the right external iliac artery.The patency within the riia stent could not be confirmed.On the left side the contra limb was extended into the left external iliac artery.The left common iliac was also aneurysmal (~2.5cm diameter), and the left internal iliac had been coiled.The stent grafts were patent, and other than the aortic body infolding no limb compression or kinks were observed.No vessel occlusion was seen distal to the stent grafts, other than the stented right internal iliac stent.No other stent graft issues were observed.The cause of the type iii junctional endoleak reported during implant could not be determined from the films provided.Pre-implant films and images during implant were not available for review, and the films from 3-days post-implant did not reveal any obvious endoleak.The cause of the drop in red blood cells and high bilirubin reported 14 days post-implant could not be determined from the films and clinical information provide.Films from this date were not available for review.It could not be concluded if there was a possible patient reaction to the stent graft implant.It is also unclear if the small bubbles seen within the aaa at 3 days post-implant may be related to this event.

Manufacturer Narrative

Film evaluation results are: a review of pre-implant films revealed that the patient had a 7cm max diameter aaa, which was lined with calcification and contained thrombus.The right common iliac was also aneurysmal (5.8cm), the left common iliac measured 2.5cm maximum, and the left internal iliac was 3.5cm maximum diameter.The proximal neck flow lumen diameter just below the renals measured ~28mm.The infrarenal neck was severely angulated ~60 deg (l-r) relative to the distal aorta, and ~50 deg (p-a) relative to the proximal aaa sac.The iliacs were extensively calcified; bilaterally.The cause of the type iii junctional endoleak reported during implant could not be determined from the pre-implant films provided.Images during implant were not available for review, and the films from 3-days post-implant did not reveal any obvious endoleak.The cause of the drop in red blood cells and high bilirubin reported 14 days post-implant could not be determined from the films and clinical information provide.Films from this date were not available for review.It could not be concluded if there was a possible patient reaction to the stent graft implant.It is also unclear if the small bubbles seen within the aaa at 3 days post-implant may be related to this event.

• Brand Name: ENDURANT II ILIAC 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 CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 5392074
• MDR Text Key: 36886170
• Report Number: 2953200-2016-00159
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/17/2016

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: 05/11/2017
• Device Model Number: ETLW1613C93EE
• Device Catalogue Number: ETLW1613C93EE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2016
• Initial Date FDA Received: 01/26/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/19/2016; 03/16/2016; 04/05/2016
• Date Device Manufactured: 05/12/2015
• 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: 00065 YR