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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problems Surgical procedure, additional (2564); No Code Available (3191)

Event Date 05/04/2015

Event Type  Injury  

Event Description

The (b)(6) year old male patient initially underwent an abdominal aortic aneurysm repair approximately 1 year prior.On (b)(6) 2015 the patient underwent a second procedure due to the zenith flex with spiral-z technology aaa endovascular graft iliac leg migrating.The migration caused a type 1b endoleak.Two additional iliac legs were used to cover the endoleak with no harm to the patient.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

(b)(4).Investigation/evaluation: during the course of the investigation, a review of the complaint history, documentation, and instructions for use (ifu) of the product was conducted.No product or medical imaging was provided.The zenith device has completed design control requirements demonstrating that the device meets the predetermined requirements and that the requirements meet the needs of the user.Specifically, design verification testing included water permeability testing, migration resistance testing, and radial force testing.The results met the acceptance criteria.The ifu provides instructions for use, contraindications, warnings and precautions regarding the appropriate method of use.Specifically, it states "additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing an enlarging aneurysm, unacceptable decrease in fixation length (vessel and component overlap) and/or endoleak.An increase in aneurysm size and/or persistent endoleak or migration may lead to aneurysm rupture.Patients experiencing reduced blood flow through the graft limb and/or leaks may be required to undergo secondary interventions or surgical procedures." based on the information provided without the returned complaint device, a definitive root cause could not be determined.Per the quality engineering risk assessment (qera) no further action is required.We will continue to monitor for similar complaints.

Event Description

The (b)(6) year old male patient initially underwent an abdominal aortic aneurysm repair approximately 1 year prior.On (b)(6) 2015 the patient underwent a second procedure due to the zenith flex with spiral-z technology aaa endovascular graft iliac leg migrating.The migration caused a type 1b endoleak.Two additional iliac legs were used to cover the endoleak with no harm to the patient.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4821445
• MDR Text Key: 5838445
• Report Number: 1820334-2015-00347
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2015

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
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-24-90-ZT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/04/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 06/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/15/2016
• 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): Required Intervention
• Patient Age: 62 YR