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

Catalog Number	TFFB-32-82-ZT
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	12/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products: lunderquist wires, coda balloon, zsle grafts.(b)(6).Due to the difficulty releasing the top cap, the doctors needed to get a through and through wire up and over the bifurcation to provide traction whilst they forcibly pushed off the nose cone.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 that the nose cap of a zenith flex aaa endovascular graft bifurcated main body delivery system couldn't be pushed off the introducer to deploy the graft.Excessive force had to be used in order to finally release the top cap and deploy the stent.A male patient was reported to have an abdominal aortic aneurysm.At some point the patient fell, which caused the aneurysm to rupture.The patient was also reported to have some breathing problems and some paralysis due to the fall.The patient underwent an endovascular aneurysm repair procedure on (b)(6) 2019.When the clinician went to push off the nose cone of the delivery system, the nose cone wouldn't advance and was stuck in position even when excessive force was used to push it off.It was thought originally that the nose cone may have been twisted, causing it to get stuck, so they finished deploying the graft and took off the second safety wire to continue.The doctors needed to get a through and through wire up and over the aortic bifurcation to provide traction on the graft to prevent it moving upwards, and used the grey positioner of the delivery system to forcibly push off the nose cone.More excessive, upwards force was used to push the grey positioner onto the nose cone, and the nose cone and bare metal proximal stent were finally deployed.The graft was being deployed over a lunderquist wire.The end of the lunderquist was located up around the aortic arch.The pin vise was loosened completely during deployment.There was no vessel calcification at the site of deployment.No other adverse effects were reported for this incident.
Additional Manufacturer Narrative
H6- additional method code: analysis of data provided by user/third party (4112).Investigation - evaluation: the complainant, (b)(6) hospital located in the united kingdom, informed cook on 27dec2019 of an incident that occurred on 26dec2019 involving a zenith flex aaa endovascular graft bifurcated main body with rpn tffb-32-82-zt from lot 9748139.The patient had a fall, which the physician believed caused the patient¿s aneurysm to rupture and caused problems with breathing as well as some paralysis.An endovascular aortic repair (evar) procedure was performed.The complaint device was being deployed over a lunderquist wire and the end of the lunderquist was located near the aortic arch.No vessel calcification was observed at the deployment site and the pin vise was completely loosened during the relevant deployment steps.When the physician went to push off the top cap and deploy the complaint device¿s suprarenal stent, difficulty was encountered.The physician thought that the nose cone may have become twisted, so they proceeded to finish deploying the main body graft and removed the distal trigger wire to remove the possibility of the trigger wire being twisted and contributing to the difficulty.Difficulty was still encountered, so the physician inserted a wire and, using a ¿through and through¿ technique, threaded it into the graft limb and over the aortic bifurcation to provide traction on the graft and prevent it from moving upwards.The grey positioner was moved towards the graft and, with excessive force and upwards pushing, the top cap was removed deploying the suprarenal stent.No adverse effects to the patient have been reported.A review of the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions (mi), quality control, imaging, and specifications, as well as a visual inspection, dimensional verification, and functional test of the returned device were conducted during the investigation.One used tffb delivery system without the graft or captor sheath was returned to cook for evaluation.Upon visual inspection, a wire guide was inserted into the delivery system.The inner cannula and grey pusher were kinked at several locations and biomatter was present throughout the device.There was a slight indent on the top cap at the trigger wire hole and a scuff mark on the grey pusher proximal to the top cap.During a functional test, the pin vise was unscrewed in an attempt to push the top cap off.Resistance was noted, so the dilator tip and top cap were pulled instead.Significant damage to the trigger wire closest to the top cap was noted, likely as a result of difficulties with the trigger wire.Thick biomatter was noted on the inner cannula.Once removed, the inner cannula was able to move smoothly.The top cap was cut circumferentially from the dilator tip, the inner cannula was snipped, and the top cap was removed and cut open longitudinally.Scratch marks were noted throughout the interior of the top cap.Dimensional verification suggests that the device was manufactured to specification.The user facility also provided procedural images and a procedural fluoroscopy video, which were submitted for expert image review.Upon review, the inability to advance the top cap off the suprarenal stent was confirmed.The suprarenal stent was successfully released after troubleshooting mechanisms, but did not release before being pushed and rotated clockwise.A clockwise suprarenal stent twist in the top cap, the tighter packing of the suprarenal stent, and thoracic aortic tortuosity all contributed to difficult top cap advancement.A leftward introducer tip bend and its contact with the left lateral wall of a tortuous distal thoracic aorta would have resisted top cap advancement.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient controls and inspections are in place to prevent the release of non-conforming product related to the reported failure mode.A review of the design history file (dhf) showed that the affected product is both safe and effective for its intended use.A review of the dhrs for the complaint device lot (9748139) and the related sub-assembly lots revealed no non-conformances relevant to the failure mode.A database search found no other events associated with the reported device lot.It should be noted that this device 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), [t_zaaaf_rev5] ¿zenith flex aaa endovascular graft with the z-trak¿ introduction system¿, provides the following information to the user related to the reported failure mode: ¿4 warnings and precautions 4.5 implant procedure do not bend or kink the delivery system.Doing so may cause damage to the delivery system and the zenith flex aaa endovascular graft.To avoid any twist in the endovascular graft, during any rotation of the delivery system, be careful to rotate all of the components of the system together (from outer sheath to inner cannula).Before deployment of the suprarenal stent, verify that the position of the access wire guide extends just distal to the aortic arch.5 adverse events 5.2 potential adverse events adverse events that may occur and/or require intervention include, but are not limited to: endoprosthesis: incomplete component deployment 11 directions for use 11.1 bifurcated system 11.1.7 main body proximal (top) deployment caution: during proximal trigger-wire removal, top cap advancement, and subsequent suprarenal stent deployment, verify that the position of the main body wire guide extends just distal to the aortic arch and that support of the system is maximized.3.Loosen the pin vise.Control the position of the graft by stabilizing the gray positioner of the introducer.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.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.11.1.9 main body distal (bottom) deployment note: the distal stent is still secured by the trigger-wire.3.Remove the safety lock from the ipsilateral limb trigger-wire release mechanism.Withdrawn and remove the trigger-wire by sliding the ipsilateral limb trigger-wire release mechanism off the handle and then remove via its slot over the inner cannula.14 troubleshooting 14.2 suprarenal stent deployment troubleshooting 14.2.1 main body proximal (top) deployment 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.To add support to the inner cannula, inflate the balloon to the full diameter of the graft.Loose the pin vise.Stabilize the gray positioner and balloon catheter, and advance the inner cannula to deploy the suprarenal stent.If still unable to fully deploy the suprarenal stent: 8.Loosen the pin vise 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.The advanced gray positioner provides additional support to the inner cannula.9.Lock the pin vise.11.Reposition the molding balloon so that it is seated against the bifurcation.12.Inflate the balloon to the full diameter of the graft.13.Loosen the pin vise.14.Stabilize the gray positioner and balloon catheter and advance the inner cannula to deploy the suprarenal stent.¿ based on the information provided, inspection of the returned product as well as the provided imaging, and the results of the investigation, a definitive root cause for this event was traced to unintended user error.It was reported that the physician thought that the nose cone may have become twisted contributing to the difficulty.In reviewing the provided imaging, the image reviewer observed an approximately 30-degree counterclockwise twist in the suprarenal stent.This confirms the physician¿s theory of a twist in the system.Additionally, on the returned delivery system circumferential scratch marks were observed on the interior surface of the top cap, likely from the stent¿s barbs due to twisting of the suprarenal stent or top cap relative to the other.This further supports the physician¿s theory.This observed twisting was likely the main contributing factor to the difficulty experienced with advancing the top cap.The device ifu states, ¿to avoid any twist in the endovascular graft, during any rotation of the delivery system, be careful to rotate all of the components of the system together (from outer sheath to inner cannula).¿ it is likely that the observed twisting in the device was unintentional and occurred during delivery system introduction or device handling.Additionally, this failure mode is a known inherent risk of using tffb devices.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 9602525
• Report Number: 1820334-2020-00143
• Device Sequence Number: 2578835
• Product Code: MIH
• UDI-Device Identifier: 10827002484273
• UDI-Public: (01)10827002484273(17)210603(10)9748139
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2020

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: 06/03/2021
• Device Catalogue Number: TFFB-32-82-ZT
• Device Lot Number: 9748139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Received by Manufacturer: 12/27/2019
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1