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

Model Number	N/A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be sent upon conclusion.
Event or Problem Description
It was reported that when the physician opened the package of the zenith flex aaa endovascular graft bifurcated main body during the procedure for endovascular exclusion of abdominal aortic aneurysm (aaa), the front of the main sheath near the dilator was slightly contorted.When the medical team inducted the main sheath from the right femoral artery via bilateral approach, the device body was noted to be shortened due to sheath contortion and wrinkling.After several failed attempts, the physician switched to the left femoral approach but the device remained shortened.Since he could not ensure that the iliac legs could be opened completely, the device was removed and another device was used to successfully finish the procedure.There was no reported adverse event or injury to the patient.Of note, cta results performed pre-procedure and intraoperatively were negative for obvious vessel tortuosity but confirmed the presence of calcified plaque.No further information was provided.
Additional Manufacturer Narrative
Investigation/evaluation: (b)(4).A review of patient imaging, complaint history, the device history record, documentation, the instructions for use (ifu), quality control data, and visual inspection / functional testing of the returned device was conducted.One zenith flex aaa endovascular graft bifurcated main body was returned for investigation.A used delivery system sheath and inner pusher (with loaded graft) was returned.The tip of the flexor was twisted.The remainder of the system appeared undamaged, but it was noted that the alignment of the sidearm of the valve was not in alignment with the trigger wire knobs indicating that at some point the flexor sheath was twisted/turned.The tip material of the flexor was within specifications.It is unknown whether the twist noted in the tip of the flexor occurred during loading, shipping/handling, or preparation of the device by the user.Images of the complaint device delivery system, two pre-implantation computerized tomography (ct) scans, and angiographic images of pre-implantation and insertion were provided.The images of the delivery system confirmed the wrinkle at the tip of the sheath.A single non-conformance was noted on this device, but it was not related to the sheath.Wrinkles in the sheath are caused by a compressive force, usually due to tracking the sheath into anatomy or a valve.However, the complaint report indicates that the wrinkle was found upon opening the package.The pre-implantation ct scans were image reviewed and the findings included small diameters and severe iliac calcification of both the left and right external iliac arteries.The review confirmed that upon insertion of the device from the right, the "aortic length from the renal arteries to the aortic bifurcation was reduced to 95mm" from 100 to 110 mm.However, the tffb-26-84 produced the same effect on the aortic lumen when advanced through the left iliac arteries.Main body insertion on the left illustrates that the iliac arteries were too small to accommodate even a normal sheath without displacing the aortic bifurcation superiorly.The pre-insertion angiogram and the computerized tomographic angiography (cta) demonstrated relatively small external iliac arteries (eia) with severe calcification where the diameter was smallest.The right eia lumen diameter varied between 5.5mm and 7.3mm.The 5.5mm was just distal to the internal iliac artery (iia) origin and severely calcified.The left eia lumen diameter varied between 4.4mm and 6.3mm, which was also severely calcified and the aorta was curved to the left.The imaging review could not confirm any damage to the introducer sheath.However, the physical device evaluation conducted in the lab revealed that the tip of the flexor was twisted.According to the review, this would have aggravated aortic shortening by increasing the friction with the iliac arteries, but even a normal sheath when used in the iliac arteries that were too small and heavily calcified would have encountered the same procedural difficulty.The unsheathing would have reduced the concertinaed aorta and choosing a shorter main body guaranteed successful gate opening above the bifurcation.The sheath damage could have occurred during the shipping and handling, as the user reported damage prior to use.However, the sheath may have also become twisted during use.The procedural difficulty faced could be mostly due to very small iliacs and heavy calcification.However, this could have been aggravated due to the twisted sheath used.A review of the device history record of the finished product showed there was one non-conformance.The non-conformance listed on the device history record was for a work order error that was reworked.The instructions for use (ifu) provides the following related information: the zenith flex aaa endovascular graft is suitable for aneurysms having morphology suitable for endovascular repair, including: adequate iliac/femoral access compatible with the required introduction system and iliac artery distal fixation site greater than 10mm in length and 7.5-20mm in diameter.Access vessel diameter and morphology should be compatible with vascular access techniques and delivery system of a 16 french to 22mm french vascular introducer sheath.Vessels that are significantly calcified, occlusive, tortuous or thrombus lined may preclude placement of the graft.Vascular conduit technique may be necessary to achieve success in some patients.Inspect the device and packaging to verify that no damage has occurred or if the sterilization barrier has been damaged or broken.If damage has occurred, do not use the product and return to cook.Based on the available information and results of our investigation, a definitive root cause for sheath contortion could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.Appropriate personnel have been notified of this event.

• 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: 6606139
• Report Number: 1820334-2017-01007
• Device Sequence Number: 994700
• Product Code: MIH
• UDI-Device Identifier: 10827002484136
• UDI-Public: (01)10827002484136(17)181230(10)7521556
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2017

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: N/A
• Device Catalogue Number: TFFB-26-96-ZT
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 45