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

Model Number	G48418
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: initially implanted: right: zsle-20-74-zt, lot# 9039832 left: zsle-16-74-zt, lot # 8750570.(b)(4).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 a patient developed a type 1 endoleak after implantation of a zenith flex aaa endovascular graft bifurcated main body.Following the initial procedure, the patient presented as symptomatic.After the discovery of a large type 1 endoleak, the patient underwent a secondary procedure in which a cook extension graft was placed and ballooning was performed below the patient's left renal.At this stage, the endoleak did not resolve, so ten competitor screws were placed and the area was ballooned again.Ultimately, a competitor bare stent graft was placed.Afterwards, a "slight blushing" leak was still noted as the endoleak did not completely resolve.During the procedure, the patient was on a coumadin regimen and was heparinized.The patient remained in the hospital and is said to be stable and "doing well".Additional information regarding the patient has been requested but is currently unavailable.More details on the secondary procedure and the endoleak from the esbe device are reported on an mdr with patient identifier (b)(6).
Event or Problem Description
No additional patient/event information has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
H6 ¿ method code: (4114) device not returned.Investigation evaluation.This complaint involves a patient with a tffb-28-96-zt who presented to the hospital with a large type i endoleak and was symptomatic.A coda balloon was used and inflated to 25cc before any additional devices were placed.Ballooning was done below the patient's left renal.Then, an esbe-32-39-zt (reported under mdr# 1820334-2020-00697) was placed and ballooned with a 32 coda balloon.The endoleak did not resolve, so ten (10) medtronic aptus screws were placed, followed by more ballooning of the area.Ultimately, a cordis palmaz stent was placed.A slight blushing leak was still noted, and the patient remained in the hospital an additional day.A review of the documentation including the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control and specification of the device was conducted during the investigation.The complaint device was not returned for evaluation and no imaging was provided for review.However, a document based investigation evaluation was performed.A review of the device master record found that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file found that through design validation and verification testing, the affected product is safe and effective for its intended use.A review of the device history record and a database search for lot 8522089 found no nonconformances or additional complaints related to this failure mode.As there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.There is no evidence to suggest the device was not manufactured to specification.Additionally, a review of the product labeling for the device was completed.The instructions for use state the following instructions related to the reported failure mode: indications for use: "the zenith flex aaa endovascular graft with the z-trak introduction system is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair, including: adequate iliac/femoral access compatible with the required introduction systems, non-aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm: o with a length of at least 15mm, o with a diameter measured outer wall to outer wall of no greater than 32mm and no less than 18mm, o with an angle less than 60 degrees relative to the long axis of the aneurysm, and o with an angle less than 45 degrees relative of the axis of the suprarenal aorta.Iliac artery distal fixation site greater than 10mm in length and 7.5-20mm in diameter (measured outer wall to outer wall)." potential adverse events: "aneurysm enlargement"."aneurysm rupture and death"."bleeding, hematoma or coagulopathy"."cardiac complications and subsequent attendant problems (e.G., arrhythmia, myocardial infarction, congestive heart failure, hypotension, hypertension)" "endoleak".Warnings and precautions: "additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing an enlarging 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." "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 (<15mm); an inverted funnel shape (greater than 10% increase in diameter over 15mm 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 site.Necks exhibiting these key anatomical elements may be more conducive to graft migration or endoleak.¿ "strict adherence to the zenith flex aaa endovascular graft ifu sizing guide is strongly recommended when selecting the appropriate device size.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." "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." "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." "additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing an enlarging 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." imaging guidelines and postoperative follow-up: "12.6 additional surveillance and treatment: additional surveillance and possible treatment is recommended for: o aneurysms with type i endoleak.O aneurysms with type iii endoleak.O aneurysm enlargement, greater than or equal to 5mm of maximum diameter (regardless of endoleak status).O migration o inadequate seal length.Consideration for re-intervention or conversion to open repair should include the attending physician¿s assessment of an individual patient¿s co-morbidities, life expectancy and the patient¿s personal choices.Patients should be counseled that subsequent re-interventions including catheter based and open surgical conversion are possible following endograft placement." based on the information provided, no inspection of the product, and the results of the investigation, a definitive cause for the endoleak was established as patient condition, as the patient had a reverse funnel/angled neck shape anatomy.Additionally, endoleaks are a known inherent risk of these devices.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook 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: 9886190
• Report Number: 1820334-2020-00696
• Device Sequence Number: 19529182
• Product Code: MIH
• UDI-Device Identifier: 10827002484181
• UDI-Public: (01)10827002484181(17)200129(10)8522089
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2020

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: 01/29/2020
• Device Model Number: G48418
• Device Catalogue Number: TFFB-28-96-ZT
• Device Lot Number: 8522089
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 06/25/2020
• 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