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

Model Number	G48429
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: zsle-20-90-zt - lot #9467124, zsle-24-90-zt - lot #9470723, cook coda balloon, cook lunderquist wire, cook beacon tip catheter, terumo glide wire, terumo pinnacle sheath.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported the tffb main body top cap would not push off of barbs/uncovered segment.The surgeon had to use manual device to force the release.There was some limited vessel calcification but none in the infra-renal neck.There was no aortic tortuosity and very limited iliac tortuosity.The endovascular aneurysm repair (evar) was completed successfully as the physician was able to land the device in the planned target zone.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: d10, h3.Investigation - evaluation: a review of the documentation including the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions (mi), and quality control, as well as a visual inspection and dimensional verification of the returned device was conducted during the investigation one used tffb-32-111-zt delivery system (including the delivery system subassembly, sheath, peel away, trigger wires, and wire guide) and lunderquist wire guide were returned to cook for evaluation.Upon visual inspection, it was noted that the graft had been deployed from the system and biomatter was present throughout the components.The sheath, trigger wires, and peel away were returned separated from the delivery system.The pin vise was unscrewed and separated from the trigger shaft.The dilator was docked to the bottom cap of the gray pusher.The distal and proximal trigger wires were noted to be bent.After incisions were made, light scratches were noted within the inside of the top cap.Medical tape was initially wrapped around the trigger shaft and trigger wire holes upon return.Upon removal, no abnormalities were observed.The pin vise was able to easily slide over the inner cannula and could be re-tightened to the trigger shaft.The inner cannula was bent between the pin vise and black cannula hub.Dilator and top cap advancement was attempted by advancing the inner cannula.Resistance was felt and it was not possible to advance the inner cannula.The dilator/top cap assembly was pulled away from the bottom cap and dried biomatter came out from in between the inner cannula and bottom cap.The dried biomatter was cleaned from the inner cannula and the inner could be easily advanced and withdrawn from the proximal end of the device.The failure mode could not be verified because the graft was implanted during the procedure and not returned for evaluation.There is no evidence to suggest that product was not manufactured to current specifications.Additionally, a document -based investigation evaluation was performed.Cook has concluded that sufficient controls and inspections are in place to prevent the release of non-conforming product related to the reported failure mode.Design testing showed that the affected product is safe and effective for its intended use.A review of the dhrs for the complaint lot (9456483) and related subassembly lots found no related non-conformances.A database search found this to be the only event associated with the provided complaint lot.Furthermore, the tffb-32-111-zt is a one-device lot.Because there are adequate inspection activities in place, objective evidence that the dhr was fully executed, no related non-conformances, and no other lot-related complaints received from the field, cook has concluded that there is no evidence that non-conforming product exists in house or in field.Cook also reviewed product labeling.The product instructions for use (ifu) provides the following information to the user related to the reported failure mode: "4 warnings and precautions: 4.2 patient selection, treatment and follow-up; key anatomical elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation (>60 degrees for infrarenal neck to axis of aaa or >45 degrees for suprarenal neck relative to the immediate infrarenal neck); short proximal aortic neck (<15 mm); an inverted funnel shape (greater than 10% increase in diameter over 15 mm of proximal aortic neck length); and circumferential thrombus and/or calcification at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.In the presence of anatomical limitations, a longer neck may be required to obtain adequate sealing and fixation.Irregular calcification and/or plaque may compromise the attachment and sealing at the fixation sites.Necks exhibiting these key anatomical elements may be more conducive to graft migration or endoleak.4.5 implant procedure the zenith flex aaa endovascular graft incorporates a suprarenal stent with fixation barbs.Exercise extreme caution when manipulating interventional and angiographic devices in the region of the suprarenal stent.11 directions for use: 11.1 bifurcated system; 11.1.7 main body proximal (top) deployment; 4.Deploy the suprarenal stent by advancing the top cap inner cannula 1 to 2 mm at a time while controlling the position of the main body until the top stent is fully deployed.(figs.15 and 16) advance the top cap cannula an additional 1 to 2 cm and then retighten the pin vise to avoid contact with the deployed suprarenal stent.Note: if unable to fully deploy suprarenal stent by advancing the top cap inner cannula, see section 14.2, suprarenal stent deployment troubleshooting.14 troubleshooting: 14.2 suprarenal stent deployment troubleshooting; caution: the following steps should be performed only if unable to deploy the suprarenal stent as described in section 11.1.7.1.If the suprarenal stent cannot be fully deployed by advancing the top cap inner cannula, advance a molding balloon through the contralateral limb of the main body and position it just superior to the bifurcation of the stent graft.2.To add support to the inner cannula, inflate the balloon to the full diameter of the graft.3.Loosen the pin vise.(fig.14).4.Stabilize the gray positioner and balloon catheter, and advance the inner cannula to deploy the suprarenal stent.If the suprarenal stent is fully deployed: 5.Tighten the pin vise; deflate and withdraw the balloon.6.Advance the contralateral wire guide into the thoracic aorta and return to the appropriate step in the instructions for use to complete the procedure.If still unable to fully deploy the suprarenal stent: 5.Tighten the pin vise and deflate the balloon.While maintaining balloon position, stabilize the gray positioner and withdraw the sheath to fully deploy the ipsilateral limb.6.Remove the safety lock from the ipsilateral limb trigger-wire release mechanism.7.Withdraw and remove the trigger-wire by sliding the ipsilateral limb trigger-wire release mechanism off the handle, and remove via its slot over the device inner cannula.8.Loosen the pin vise (fig.22) and, while maintaining inner cannula position, advance the gray positioner and sheath into the graft until the tip of the gray positioner is approximately 2 cm inferior to the proximal gold markers.(fig.46) the advanced gray positioner provides added support to the inner cannula.Note: take care not to advance the graft during gray positioner and sheath advancement.Note: ensure that the tip of the gray positioner is not advanced into the top cap.9.Lock the pin vise.10.Verify position of the gold markers inferior to the renal arteries.11.Reposition molding balloon so that it is seated against the bifurcation.12.Inflate the balloon to the full diameter of the graft.(fig.37) 13.Loosen the pin vise.14.Stabilize the gray positioner and balloon catheter, and advance the inner cannula to deploy the suprarenal stent.15.Tighten the pin vise.16.Deflate the balloon and advance the contralateral wire guide into the thoracic aorta.Note: due to early ipsilateral leg deployment and trigger-wire release, it is suggested to leave the molding balloon in or just above the contralateral limb for use in graft stabilization during placement of the ipsilateral limb." based on the information provided, evaluation of the returned product, and the results of our investigation, a definitive root cause could not be established.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is require at this time.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 8546667
• Report Number: 1820334-2019-00524
• Device Sequence Number: 11195281
• Product Code: MIH
• UDI-Device Identifier: 10827002484297
• UDI-Public: (01)10827002484297(17)210127(10)9456483
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2019

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 Expiration Date: 01/27/2021
• Device Model Number: G48429
• Device Catalogue Number: TFFB-32-111-ZT
• Device Lot Number: 9456483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 113