MAUDE Adverse Event Report: COOK, INC. ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Device Problem Occlusion Within Device (1423)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Date 01/19/2015

Event Type  Injury  

Event Description

In (b)(6) 2013, a (b)(6) male patient had an aaa repair with evar, as well as an assessment size of aaa, position of stent graft and to rule-out endoleaks.Based on the results by a study conducted, a small type ii endoleak was detected, barely visible.No enlargement of the aneurysm.It was noted that the left iliac limb of the graft is occluded.A comparison was made to multiple previous exams.Noncontrast arterial and delayed phase images were obtained.The evar graft has bifurcated right iliac limb, supplying both the internal and external iliac arteries.The left iliac limb extends into the common iliac artery.What could possibly be a minuscule endoleak visible in the posterior aspect of the sac is detected, measuring only a few millimeters in diameter.The aneurysm was measured to be about 5.1 x 4.6 cm in diameter, with no significant change compared to the previous.The right common iliac artery is smaller now, about 1.8 cm in maximum diameter, compared to 2.4 cm on the pre-evar ct.A mural thrombus seen within the main body of the stent graft, along with the left lateral aspect, and the entire left limb of the graft is occluded.Reconstitution of the internal and external iliac arteries is detected as well, with a very short stump of the distal common iliac also opacified.The right iliac limb of the graft, including the internal iliac branch is widely patent and the internal and external iliac arteries are normal.Incidental note was made of a right inguinal hernia, which contain at least a portion of a small bowel loop.This hernia was only partially scanned, but was not present previously.There was also a smaller, fat-containing left inguinal hernia, which looks unchanged.The lung bases looked clear.The liver, spleen and kidneys appeared normal.The small right adrenal nodule looked unchanged.

Manufacturer Narrative

(b)(4).The event is currently under investigation.More information will be provided upon conclusion.

Manufacturer Narrative

Event evaluation: during investigation, a review of complaint history, instructions for use (ifu), and trends was conducted.Each (b)(4) device is shipped with instructions for use (ifu) listing the indications for use, contraindications, warnings and precautions, and the correct deployment procedure.In regards to occlusions, the ifu lists several warnings/precautions that, if followed, could prevent this failure mode from occuring or lessen the associated effects, anatomical criteria, anatomical conditions, importance of accurate placement.Specific to this case (b)(4) ifus state "patients experiencing reduced blood flow through the graft limb and/or leaks may be required to undergo secondary interventions or surgical procedures." 'vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement of the endovascular graft and/or may increase the risk of embolization." the returned imaging in this case was forwarded for expert review.The reviewer assessed that there was no anatomic reason for occlusion.It was concluded that the failure mode for this case was occluded.Risk assessment procedure were used to evaluate risk.The event was trended as low impact to the patient.Based on the information, a definitive root cause can not be determined or reported at this time.There is no evidence to suggest that the device design or functionality contributed to this event.We will continue to monitor for similar complaints and notify the appropriate internal personnel.

• Brand Name: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4564867
• MDR Text Key: 19724039
• Report Number: 1820334-2015-00107
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2015

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/19/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/19/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/05/2015
• Initial Date FDA Received: 02/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 64 YR