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

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problems Surgical procedure, additional (2564); Blood Loss (2597); No Code Available (3191)

Event Date 04/08/2015

Event Type  Injury  

Event Description

During an evar procedure on a (b)(6) male patient, the physician was unable to push up the top cap on a zenith main body graft.After introducing the main body, checking the renals, deploying the covered stent and cannulating the contralateral limb.When the physician attempted to deploy the bare stents by pulling on the wires to push off the top cap, it was not possible without lifting the graft.He tried repeatedly, also with force, but this was not possible.The physician states there was no other option, but to perform open surgery and cut through the main body in order to remove the graft.According to the initial reporter, the patient underwent open surgery which resulted in loss of blood and other eventual complications.Additional information was requested but not provided at the time of this report.

Manufacturer Narrative

(b)(6).The event is currently under investigation.

Manufacturer Narrative

(b)(4.

Event Description

During an evar procedure on a 77 year old male patient, the physician was unable to push up the top cap on a zenith main body graft.After introducing the main body, checking the renals, deploying the covered stent and cannulating the contralateral limb.When the physician attempted to deploy the bare stents by pulling on the wires to push off the top cap, it was not possible without lifting the graft.He tried repeatedly, also with force, but this was not possible.The physician states there was no other option, but to perform open surgery and cut through the main body in order to remove the graft.According to the initial reporter, the patient underwent open surgery which resulted in loss of blood and other eventual complications.Additional information was requested but not provided at the time of this report.

Manufacturer Narrative

(b)(4).Investigation - 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.There was no evidence to suggest the device was not manufactured to specifications.A review of the instructions for use (ifu), provided imaging, an independent review by our clinical expert, and complaint history were reviewed as part of the investigation.Each device is sent with an ifu, which describes the indications for use, warnings, precautions, and the proper deployment sequence.Specific to this case, the ifu states: "read all instructions carefully.Failure to properly follow the instructions, warnings and precautions may lead to serious consequences or injury to the patient." the ifu also recommends using a cook (b)(6) extra stiff wire guide (les).Additionally, prior to removing the proximal trigger wire, the ifu instructs the user to verify the wire guide is in the thoracic aorta.In addition, top cap deployment troubleshooting is detailed in the products ifu.The following observations were made on the returned device: the tipped end of the gray positioner was examined.The holes of the gray positioner did not appear to exhibit evidence of a high amount of force applied to them during use.The ipsilateral limb of the graft was examined for stress transferred to it by the ipsilateral limb trigger wire.No evidence of stress, in the way of graft damage, elongation of graft/suture holes, or tearing, was found to be present.The solder of the suprarenal stent barbs were visually examined.The solder appeared consistent and not excessive.The id of the top cap was examined from the clinically distal end.The cap was observed to be slightly out of round.Minor deformation of material was noted, however not consistent with barbs catching on the id of the top cap.Light longitudinal scratches were observed on the flexor sheath.Damage on the flexor sheath at about 9.5 cm was noted.The provided imaging in this case was forwarded for clinical expert review.The reviewer observed the following: the primary reason for top cap removal difficulty was likely ipsilateral limb deployment before attempted top cap removal.First, the operator states he removed all trigger wires, not just the distal trigger wire, and then attempted to release the suprarenal stent.Second in the 22 minutes separating partial mainbody unsheathing and imaging with the proximal positioner advanced to the suprarenal stent, a number of steps needed to take place.The contralateral gate needed unsheathed and cannulated from the zbis.The mainbody would have been advanced and position checked angiographically.The distal trigger wire would have been released and suprarenal stent deployment attempted.A number of attempts would have made without success.Then the ipsilateral gate deployment and proximal positioner advancement would have been completed as a troubleshooting remedy to the stuck topcap.This could have been accomplished in 22 minutes but only by an operator familiar with troubleshooting procedures.It is unlikely this operator was familiar with the troubleshooting procedures as this operator queries whether difficulty removing the topcap has ever happened before.The anatomy was challenging for topcap removal.The iliac artery and aorta were tortuous.Even with the sheathed endograft straightening the aorta, 35 degrees of neck aneurysm angulation was present.The topcap was in contact with the suprarenal aortic wall to such an extent that the topcap was slightly bent.The waist type neck morphology was outside ifu parameters.Additionally waist type necks such as this are often associated with aortic angulation outside the ifu.The proximal tffb was slightly kinked.This would have increased top cap removal force." review of product lot records did not identify any issues or concerns specific to the failure mode in this case.Conversation with a cook representative for aortic intervention (ai), who speaks german was conducted, and an audit of the translation provided by another cook representative was requested.Specifically focusing on the dialogue surrounding the point during top cap advancement of the device, as well as trigger wire removal.It was requested if the user detailed if he initially pulled out one or two trigger wires prior to attempting to advance the top cap.Our ai representative believed that the document detailed that the user removed one trigger wire, in accordance with the ifu, prior to experiencing the difficulty.He believes that after the difficulty occurred, the user then pulled both wires as an effort to trouble shoot the issues he was experiencing.Our ai representative also commented that the user of the device was an experienced zenith user.Based on this evaluation, the root cause for the failure of the device could not be determined.The appropriate internal personal have been notified at this time.

Event Description

During an evar procedure on a (b)(6) year old male patient, the physician was unable to push up the top cap on a zenith main body graft.After introducing the main body, checking the renals, deploying the covered stent and cannulating the contralateral limb.When the physician attempted to deploy the bare stents by pulling on the wires to push off the top cap, it was not possible without lifting the graft.He tried repeatedly, also with force, but this was not possible.The physician states there was no other option, but to perform open surgery and cut through the main body in order to remove the graft.According to the initial reporter, the patient underwent open surgery which resulted in loss of blood and other eventual complications.Additional information was requested but not provided at the time of this report.

• Brand Name: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4766572
• MDR Text Key: 21548864
• Report Number: 1820334-2015-00275
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Model Number: N/A
• Device Catalogue Number: TFFB-30-96-ZT
• Device Lot Number: 5312283
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/08/2015
• Device Age: 6 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/13/2015
• Initial Date FDA Received: 05/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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): Required Intervention
• Patient Age: 77 YR