MAUDE Adverse Event Report: COOK INC ZENITH FLEX WITH Z-TRAK AAA ENDOVASCULAR GRAFT MAIN BODY EXTENSION; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G55209
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	Malfunction
Additional Manufacturer Narrative
Concomitant products: originally implanted: cook- right: zsle-20-74-zt, lot# 9039832; left: zsle-16-74-zt, lot # 8750570; tffb-28-96-zt, lot # 8522089.Secondary procedure: cook- 32 coda balloon.Non-cook- 10 medtronic aptus screws; cordis palmaz stent.(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 type 1 endoleak persisted after placement of a zenith flex with z-trak aaa endovascular graft main body extension.The patient presented symptomatic following the implantation of a cook main body graft and two cook leg grafts.A large type 1 endoleak was discovered, resulting in the placement of a main body extension graft in a secondary procedure (which is the subject of this complaint).Following placement, the graft was ballooned in the left renal using a cook coda balloon inflated to 25 cc.However, the endoleak still remained, so ten competitor screws were placed and the area was re-ballooned.Ultimately, a competitor bare stent graft was placed.Afterwards, a "slight blushing" leak was still present, but the physician decided to leave it as is as the leak had "drastically improved".The patient was on a coumadin regimen and was heparinized during the procedure.The patient remained in the hospital but was said to be currently stable and "doing well".Additional information regarding the patient has been requested but is currently unavailable.The initial type 1 endoleak on the cook main body graft is reported under mdr: 1820334-2020-00696.
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: it was reported, a patient had a tffb-28-96-zt placed 23apr2019 (under mdr# 1820334-2020-00696).Less than a year later, the patient 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 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, drawing, device history record, instructions for use (ifu), manufacturing instructions, quality control and specifications 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 8749051 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 aaa ancillary components with the z-trak introduction system are indicated for use with the zenith aaa graft during either a primary or a secondary procedure in patients who have adequate iliac/femoral access compatible with the required introduction systems." potential adverse events: "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.¿ ¿ successful patient selection requires specific imaging and accurate measurements.¿ "strict adherence to the zenith aaa graft ancillary components 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 aaa graft ancillary components 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." 4.6 molding balloon use: ¿ do not inflate balloon in the vessel outside of graft as doing so may cause damage to the vessel.Use the balloon in accordance with its labeling.¿ use care in inflating the balloon within the graft in the presence of calcification, as excessive inflation may cause damage to the vessel.¿ confirm complete deflation of the balloon prior to repositioning.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 WITH Z-TRAK AAA ENDOVASCULAR GRAFT MAIN BODY EXTENSION
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9886248
• Report Number: 1820334-2020-00697
• Device Sequence Number: 2784714
• Product Code: MIH
• UDI-Device Identifier: 10827002552095
• UDI-Public: (01)10827002552095(17)210624(10)8749051
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/24/2021
• Device Model Number: G55209
• Device Catalogue Number: ESBE-32-39-ZT
• Device Lot Number: 8749051
• 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