MAUDE Adverse Event Report: COOK INC ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G48417
Medical Device Problem Codes	Positioning Failure (1158); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The user facility in (b)(6) reported the (b)(6) male patient underwent an endovascular aneurysm repair (evar) to treat an abdominal aortic aneurysm (aaa).Since there was an aneurysm in the right common iliac artery (cia), the right iliac artery aneurysm (iia) was embolized with coils prior to the stent graft placement.After the embolization of the right iia was completed, angiography was conducted with a pig-tail catheter with markers (device unknown) and the distance of the area between the inferior renal artery (ra) and the terminal aorta was measured.Taking the result of the measurement into the consideration, the physician determined to place a zenith flex aaa endovascular graft bifurcated main body in the patient.After flushing the zenith flex aaa endovascular graft bifurcated main body, the delivery system was advanced to the target site.Then, the physician attempted to withdraw the sheath back to deploy the stent graft.However, the sheath was too stiff and difficult to pull back.The physician continued trying to withdraw the sheath back for approximately 10 minutes, but it could not be pulled back at all, and the stent graft could not be deployed.Another zenith flex aaa endovascular graft bifurcated main body of a different size was deployed without any problems.The procedure was completed successfully.According to the reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Other relevant medical history: unspecified infectious disease.Concomitant products: unknown embolization coils, unknown pigtail catheter.Investigation/evaluation: the zenith flex aaa endovascular graft bifurcated main body was not returned for an evaluation.The user facility advised the device was discarded due to infectious disease.No images or procedural notes were provided, but the planning and sizing sheet was provided.Without the complaint device, a physical investigation could not be performed.A review of complaint history, the device history record, instructions for use, and quality control data was conducted.The quality control specification and design history files were reviewed and no evidence was found that the device is manufactured out of specification.Review of the device history record of the finished product shows no nonconforming events that would contribute to the reported failure mode.There were no other reported complaints for this lot number.Each zenith device is shipped with instructions for use (ifu), that lists the indications for use, contraindications, warnings and precautions, and the correct deployment procedure.Per the ifu: "inspect the device and packaging to verify that no damage has occurred as a result of shipping.If damage has occurred, do not use the product and return to cook.Adequate iliac or femoral access is required to introduce the device into the vasculature.Access vessel diameter and morphology should be compatible with vascular access techniques and delivery systems of a 16 french to 22 french vascular introducer sheath.Do not bend or kink the delivery system.Doing so may cause damage to the delivery system and the zenith flex aaa endovascular graft.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."."do not bend or kink the delivery system.Doing so may cause damage to the delivery system.Be careful to rotate all of the components of the system together.Always keep the sheath for optimal performance.The main body delivery system features a flexor introducer sheath which resists kinking and is hydrophilically coated.Both features are intended to enhance trackability in the iliac arteries and abdominal aorta." the possible causes for facing deployment difficulties include: the hydrophilic coating is not activated, tortuous anatomy, any bend or kink in the delivery system due to continued advancement when resistance is encountered, or the captor valve on the sheath is not turned to the open position.Based on the planning and sizing sheet that has been provided, it is evident that the patient had a tortuous anatomy, the abdominal aortic neck diameter and the iliac diameters are tortuous with varying diameters.As such, it is possible that the root cause for the reported difficulty in deploying the stent is patient condition-related.Per the quality engineering risk assessment, no further action is warranted.The appropriate personnel have been notified of this event.Monitoring will continue to be performed for similar complaints.

• Brand Name: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7010632
• Report Number: 1820334-2017-03503
• Device Sequence Number: 16443416
• Product Code: MIH
• UDI-Device Identifier: 10827002484174
• UDI-Public: (01)10827002484174(17)181005(10)7302713
• Combination Product (Y/N): N
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2018

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
• Operator of Device: Health Professional
• Device Model Number: G48417
• Device Catalogue Number: TFFB-28-82-ZT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR