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

Catalog Number ZSLE-13-74-ZT

Device Problem Kinked (1339)

Patient Problem Surgical procedure, additional (2564)

Event Date 07/18/2013

Event Type  malfunction  

Event Description

On (b)(6) 2013, an evar was performed on a (b)(6) female patient.During the procedure, the physician noticed a kink on the left spiral-z limb graft.The limb was reinforced with a 12 mm x 20 mm lifestar stent (1820334-2015-00112.Prior to this incident, the physician had placed a zefen aaa endovascular graft proximal body graft proximal component and a zefen aaa endovascular distal bifurcated body graft distal component.One 6 mm x 22 mm atrium icast stent was placed in the right renal artery.One 6 x 22 mm atrium icast stent was placed in the left renal artery.The implanting physician noted difficulty deploying the fenestration stents - the left renal fenestration was not aligned upon deployment.At the conclusion of the case, the endovascular graft and both fenestrated and stented renal arteries were pt.A proximal type 1 endoleak was not at the proximal landing zone but was not treated.The pt's estimated blood loss was 800 cc and the pt received 100 cc of prbcs and 250 cc of ffp intra-operatively.No pt-related adverse events were observed during the procedure.On (b)(6) 2013, a post-procedure ct scan was done.The site noted a pt, intact endograft and pt, intact renal artery stents.No kink or endoleak was noted.Core lab analysis is not yet available.The pt was discharged from the hospital on (b)(6) 2013.On (b)(6) 2013, a ct scan was done.The site noted a pt, intact endograft and patient, intact renal artery stents.No kink or endoleak was noted.Core lab analysis is not yet available.On (b)(6) 2014, a ct scan was done.Info from the site is incomplete at this time.Core lab analysis is not yet available.On (b)(6) 2014, a ct scan was done.The site noted a pt, intact endograft and pt, intact renal artery stents.No kink or endoleak was noted.Core lab analysis is not yet available.No adverse events have een reported for this pt.

Manufacturer Narrative

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

Manufacturer Narrative

Event eval: during investigation, a review of pt imaging records, device complaint history, instructions for use (ifu), and trends was conducted.Each zenith 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 occurring or lessen the associated effects: anatomical criteria, anatomical conditions, importance of accurate placement.Specific to this case, zenith 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 conclusive, tortuous or thrombus-lined may preclude placement of the endovascular graft and/or may increase the risk of embolization." the available imaging in this case was reviewed by an expert reviewer.The reviewer assessed: "the left zsle kink occurred in a severely tortuous and calcified left common iliac artery." it was concluded that the failure mode for this case was kinked.Risk assessment was used to evaluate risk.The event was trended as moderate harm to the pt.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: 4669217
• MDR Text Key: 5694193
• Report Number: 1820334-2015-00112
• 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: Study,Health Professional,User Facility,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZSLE-13-74-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: 07/18/2013
• Device Age: NA
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/03/2015
• Initial Date FDA Received: 04/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2015
• 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; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 74