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

Model Number	G48407
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/21/2017
Type of Reportable Event	Serious Injury
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
A (b)(6)-year old male patient with an abdominal aortic aneurysm (aaa) underwent aaa repair.No notable anatomical problem such as calcification or tortuous anatomy were observed.A zenith flex aaa endovascular graft bifurcated main body was inserted from the left femoral and placed right below the renal arteries.Another manufacturer's device was placed to right above the internal iliac artery in the contralateral side through the other manufacturer's 14fr sheath.After deploying the ipsilateral limb of the main body, the delivery system was removed and another manufacturer's 18fr sheath was inserted and the other manufacturer's device was placed right above the internal iliac artery.Touch-up ballooning was performed using coda-10.0-35-100-32, and angiography was performed.Type iii endoleak from the distal edge of the third stent and type ib endoleak from the ipsilateral leg were found.Another manufacturer's device was placed to treat the type ib endoleak.The physician confirmed the type iii endoleak again performing angiography from the sheath in the ipsilateral side and the angiography inside the main body.The leak had the same 'blowing-off' appearance at the same location in both angiography.To treat the type iii endoleak, another manufacturer's device was placed, but the endoleak was not resolved.The physician placed additional devices by another manufacturer in the left and right legs as both proximal ends were in the main body, and touch-up ballooning for each of the legs was performed at the same time using two coda-10.0-35-100-32 inserted from the right and the left.The leak was still not resolved.There was no further way to treat it, so the physician decided to take wait-and-see approach and completed the procedure.No information provided as to patient status post-procedure.Additional event, device and patient information has been requested but not yet received at the time of this report.
Additional Manufacturer Narrative
Additional information: on (b)(6) 2017, it was reported that ¿the type iii endoleak seems to be gone as of today.¿ however another leak was confirmed, which appeared to be a type ii endoleak.The patient was reportedly "doing fine".Investigation - evaluation: a review of the complaint history, device history record, instructions for use, manufacturing instructions, quality control data, and visual inspection of provided imaging were conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.A preoperative ct study and multiple video images from a subsequent angiography procedure are provided along with the complaint report.Visual inspection of the provided imaging was performed.There is an infrarenal abdominal aortic aneurysm (aaa) and bilateral iliac artery ectasia treated with a zenith flex main body device and bilateral iliac legs.There is a type 3b endoleak from the main body device just above the flow divider.The different angiography views and maneuvers rule out a type 1a endoleak.Attempts to re-line this segment of the main body device with an aortic cuff and additional iliac legs are unsuccessful.At the conclusion of the case, the type 3b endoleak persists.The physician reported using a coda balloon in the main body device after implantation but it is not clear if this could have contributed to the graft defect.There is no obvious calcification in this segment of the aorta that could cause a tear in the graft.Contrast injection, after the placement of two additional legs on the right and left extending into the main body device proximally, shows a persistent type 3b endoleak at the distal main body adjacent to the flow divider.However, it is not clear if the leak is from the gap between the aortic cuff and the proximal edges of the additional legs.Based on the image review, the type 3b endoleak is present just above the flow divider.Attempts to re-align this segment of the main body device with an aortic cuff and additional stent legs were unsuccessful.It was noted that the coda balloon was used in the main body device multiple times, which could have provoked suture holes causing type 3b endoleak.At the conclusion of the procedure, the type b endoleak still persists.Possible causes for type 3b endoleak could be due to incorrect suturing techniques, high blood pressure due to anatomy, outflow limitation (increased pressure increases the likelihood of provoking the suture holes) , aggressive anticoagulation use, and improper ballooning technique.However, this resolved in time.Possible causes based on the image review could be due to focal kinking or stenosis at the origin of the left external iliac artery.This could have an impact on the mainbody device, as the endoleak was noted in the mainbody above the flow divider towards the left.Kinking or stenosis would have increased the pressure in the graft and provoked suture holes.Another cause could be due to multiple use of coda balloon in the main body after the main body device placement, which could have increased the possibility of suture hole endoleak.However, it is unclear if this would have contributed to the graft defect.Details on ballooning including (inflation volume, place of ballooning and anticoagulation use) was requested but not provided.However, a definitive root cause for the type 3b/suture holes observed in this case could not be determined.Per the ifu, ¿do not bend or kink the delivery system.Doing so may cause damage to the delivery system and the zenith flex aaa endovascular graft.¿ there remains no information regarding any procedural difficulties.Per the ifu, ¿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.¿ in addition, competitor devices were used during this procedure.There is no information regarding whether these devices met their manufacturer¿s quality specifications.There is no information regarding preparation of the device.In addition, the ifu states, ¿inaccurate placement and/or incomplete sealing of the zenith flex aaa endovascular graft within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the renal or internal iliac arteries.¿ there is no information regarding sizing of the device.Per the ifu, ¿appropriate device oversizing has been incorporated into the ifu sizing guide.Sizing outside of this range can result in endoleak, fracture, migration, device infolding or compression.¿ at this time, the clinical assessment cannot eliminate any possible causes for the type iii endoleak such as product handling, medical procedure, user technique, other device compatibility, device failure, or manufacturing-related causes.Per the instructions for use: ¿do not inflate the balloon in vessel outside of the graft, as doing so may cause damage to the vessel.¿ in addition, the ifu states, ¿confirm complete deflation of balloon prior to repositioning.¿ a document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.Review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.There have been numerous design verification and design validation activities performed that have shown the device meets design input requirements and user needs.Based on the provided information, inspection of provided imaging, and the investigation, a definitive root cause for the type iiib endoleak cannot be established or reported at this time.The most likely root cause for the type ii endoleak was related to the patient's condition.Per the quality engineering risk assessment, no further action is warranted.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: 6915167
• Report Number: 1820334-2017-02886
• Device Sequence Number: 1239290
• Product Code: MIH
• UDI-Device Identifier: 10827002484075
• UDI-Public: (01)10827002484075(17)181016(10)7328115
• Combination Product (Y/N): N
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: G48407
• Device Catalogue Number: TFFB-24-82-ZT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention