MAUDE Adverse Event Report: COOK, INC. ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number ESBE-32-58

Device Problems Dissection (1186); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Perforation (2001); Atrial Perforation (2511)

Event Date 11/26/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, a male patient underwent aaa repair with left approach.Since the proximal neck was too large in diameter (35mm-36mm) and severe tortuosity and the iliac artery aneurysm in both right and left legs, the patient's anatomical form was not suitable for evar.However, it was conducted in consideration of patient condition and by patient's request.For the evar, cook's and another manufacturer's devices were planned to be used like an aorto-uni-lliac stent graft.The procedure was being conducted as planned until placement of the leg and extension grafts.When the physician advanced the delivery system of the other manufacturer's device to place it in the proximal side, it was caught on the leg extension.Since the junction between the two extensions was disconnected due to the event, one graft migrated and floated inside the aneurysm.Delivery system of the other manufacturer's device was removed.Then, delivery system of the leg extension was subsequently inserted though, it perforated abdominal aorta.Patient's overall status got worse since the perforation brought about a reduction in blood pressure.The physician judged that additional intervention for the perforation would be difficult and also switching the procedure to blood vessel prosthesis implantation would be difficult.Therefore, he decided to perform open surgery to repair the perforated site on the day.Then, the rest of prepared stent grafts were placed as planned in order.On (b)(6) 2014, implanted stent grafts, including the migrated graft, were removed from the patient and blood vessel prosthesis implantation was conducted after stabilization of the patient's condition since aaa remained even after the evar and concerns about the perforated site still remained in consideration of a possibility of type ii endoleak after the procedure.As of (b)(6) 2014, the patient had a favorable outcome though he had to be in-hospital for an extended period.

Manufacturer Narrative

(b)(4).Still under investigation.

Manufacturer Narrative

(b)(4).Event evaluation: this product line has addressed all design control requirements and shown the device has met the predetermined requirements and that those requirements meet the needs of the user.Each zenith device is shipped with instructions for use (ifu) listing the indications for use, contraindications, warnings and precautions and the correct deployment procedure.Specific to this case, the ifu states: "do not continue advancing any portion of the delivery system if resistance is felt during advancement of the wire guide or delivery system.Stop and assess the cause of resistance; vessel, catheter, or graft damage may occur.Exercise particular care in areas of stenosis, intravascular thrombosis or in calcified or tortuous vessels." "use caution during manipulation of catheters, wires and sheaths within an aneurysm.Significant disturbances may dislodge fragments of thrombus, which can cause distal embolization, or rupture of the aneurysm." "strict adherence to the zenith aaa endovascular graft ancillary components ifu sizing guide is strongly recommended when selecting the appropriate device size.Sizing outside this range can result in endoleak, fracture, migration, device infolding or compression." quality engineering risk assessment was used to assess the risk in this case.The risk remains at an acceptable level with the inclusion of this event and the event was trended as serious harm to the patient.The failure mode assigned to this case is dissection/perforation of vessel by report during insertion of a zenith main body extension device it perforated the abdominal aorta.As a result, conversion to open repair was performed, the patient was reported to have had a favorable outcome, post open repair.It was also reported that the devices used in this case were used well outside the instructions for use, however the patient was advised of this before the procedure and requested the procedure.The device ifu warns to the dangers of manipulation of devices inside previously placed grafts and the patients anatomy, as damage can occur.In addition, it was reported that the physician stated "i reckon that the event was caused by a procedural matter since the procedure had to be conducted with two manufacturers' devices (off-label use) due to anatomical conditions products did not contribute to the event." therefore, it is likely that use of the device outside the ifu contributed to this event.The event was trended as serious harm to the patient, as it was reported that the patient underwent open repair.We will continue to monitor for similar complaints and notify the appropriate internal personnel.

• Brand Name: ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4381451
• MDR Text Key: 5126971
• Report Number: 1820334-2015-00002
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002427661
• UDI-Public: (01)10827002427661(17)160911(10)5269004
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2014,12/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2016
• Device Catalogue Number: ESBE-32-58
• Device Lot Number: 5269004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/03/2014
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2014
• 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): Hospitalization