MAUDE Adverse Event Report: COOK, INC. ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

Catalog Number ZSLE-13-74-ZT

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem Thrombosis (2100)

Event Date 02/11/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, the zenith flex with spiral-z technology aaa endovascular graft iliac leg was placed.No complications were noted.On (b)(6) 2015, patient presents with left thrombosis iliac leg graft.Patient went to the operating room to undergo thrombectomy and supervision of the endograft.On (b)(6) 2015, patient left the operating room in good condition.

Manufacturer Narrative

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

Manufacturer Narrative

By report the patient began to experience symptoms indicative of occlusion 6 days post a zenith endovascular procedure.Secondary minimally invasive treatment was necessary.During the investigation, a review of the complaint history and trends as well as the instructions for use (ifu) was conducted.Each zenith device is shipped with instructions for use (ifu) listing the indications for use, contraindications, warnings & 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, occlusive, tortuous or thrombus-lined may preclude placement of the endovascular graft and/or may increase the risk of embolization." no product or imaging were returned to assist with this investigation, and only limited information was provided.Based on the information, a definitive root cause cannot 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
• Manufacturer (Section D): COOK, INC.; bloomington IN 47402
• Manufacturer Contact: larry pool, mgr. ; 750 daniels way; p.o. box 489; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4585162
• MDR Text Key: 14879310
• Report Number: 1820334-2015-00136
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002552323
• UDI-Public: (01)10827002552323(17)170501(10)4978322
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/17/2015,02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2014
• Device Catalogue Number: ZSLE-13-74-ZT
• Device Lot Number: 4978322
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/11/2015
• Device Age: 9 MO
• Event Location: Hospital
• Date Manufacturer Received: 02/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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: 64 YR