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

Model Number	G48422
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 following devices were implanted on (b)(6) 2014, with continuing aneurysm growth.G48422-tffb-30-82-zt, lot 447811 g55239-zsle-16-90-zt, lot 4247510 g55239-zsle-16-90-zt, lot 4537245 g32184-esbe-32-39, lot 3438589 in 2017, they coiled the patient's inferior mesenteric artery (ima) because they thought there was a leak.Due to persistent endoleak, an open abdominal aortic aneurysm repair was performed on (b)(6) 2018.When they opened the aneurysm to examine the device, blood was squirting through the suture holes of the device.They explanted the device.The complaint devices were disposed of by the customer.Additional patient, device and event details have been requested but have not yet been forthcoming at the time of this report.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.H6 ¿ results code: appropriate term/code not available (4247) - endoleak investigation - evaluation: a review of documentation including the complaint history, device history record, instructions for use and quality control of the device was conducted during the investigation.The complaint device and imaging of the event were not returned; therefore, no physical or visual examinations could be performed.In the absence of the complaint device and imaging, a similar complaint ((b)(4)) was referenced, as a type iiib endoleak was only observed during the explant of the device.The imaging provided in the investigation confirmed that the tffb was not leaking until explant of the device.The image reviewer stated that, ¿a type iiib endoleak large enough to spurt at explant and cause aneurysm growth would have been evident on the provided cta.Also, the mural thrombus lining the main body would have provided a seal.¿ the type iiib endoleak was attributed to the explant procedure.During the explant, the aneurysm was opened, resulting in an increased pressure differential between the flowing blood through the graft and the environment when compared to the contained graft within the aneurysm.This, along with probable anticoagulation use during the procedure, could cause a type iiib endoleak from thinned blood leaking through the graft suture holes.The device was implanted on 03jan2014; therefore, suture hole elongation due to material wear over time cannot be excluded as a possible contributing factor.Additionally, a document-based investigation evaluation was performed.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The design verification testing showed that the affected product is safe and effective for its intended use.A review of the device history showed zero nonconformances for main lot 4478117 and subassembly lot fs3510829.It should be noted that there were no other complaints reported for lot 4478117.There is no evidence to suggest that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: ¿warnings and precautions additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing a large aneurysm, unacceptable decrease in fixation length (vessel and component overlap) and/or endoleak.An increase in aneurysm size and/or persistent endoleak or migration may lead to aneurysm rupture.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 conducive to graft migration or endoleak.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysm or changes in the structure or position of the endovascular graft) should receive enhanced follow-up.Specific follow-up guidelines are described in section 12, imaging guidelines and postoperative follow-up.4.4 device selection: strict adherence to the zenith flex aaa endovascular graft ifu sizing guide is strongly recommended when selecting the appropriate device size (tables 10.5.1 through 10.5.2).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.4.5 implant procedure: 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.5.2 potential adverse events: endoleak; surgical conversion to open repair.¿.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be established.Without the explanted complaint device and imaging, there is no evidence to suggest the device was manufactured out of specification.Possible contributing factors for the aneurysm growth include the type ii endoleak reported, aneurysmal disease progression or from a small undetected type iiib endoleak.Contributing factors for the type iiib endoleak through the graft suture holes are related to the explant procedure and graft material wear over time.Per the quality engineering risk assessment no further action is required.The appropriate personnel have been notified and we will continue to monitor for similar complaints.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: 8021511
• Report Number: 1820334-2018-03082
• Device Sequence Number: 1368848
• Product Code: MIH
• UDI-Device Identifier: 10827002484228
• UDI-Public: (01)10827002484228(17)150801(10)4478117
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2015
• Device Model Number: G48422
• Device Catalogue Number: TFFB-30-82-ZT
• Device Lot Number: 4478117
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 07/03/2019
• 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
• Patient Age: 71 YR