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

Model Number	G48415
Medical Device Problem Codes	Material Disintegration (1177); Fluid/Blood Leak (1250); Separation Problem (4043)
Health Effect - Clinical Codes	Abdominal Pain (1685); Death (1802); No Code Available (3191)
Date of Event	02/28/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
(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 the suprarenal stents of a zenith flex aaa endovascular graft bifurcated main body separated, resulting in the patient's aneurysm rupturing.Consequently, the patient died.On (b)(6) 2020 (approximately 3.5 years following the original device implantation), the patient presented to the emergency department as symptomatic with both back and abdominal pain.Ct imaging showed separation of the suprarenal stents, graft disintegration, and an aneurysm rupture, so a secondary procedure in which a competitor thoracic graft was implanted was prompted.Ballooning was done in all seal zones.The issue temporarily resolved after the secondary procedure, but the patient passed "some time after" due to complications from the aneurysm rupture.Additional information regarding the patient, device, and event has been requested but is currently unavailable.
Event or Problem Description
No additional patient/event information has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Method code: (4114) device not returned.Investigation - evaluation: it was reported by dr.(b)(6) at the (b)(6) that ¿the graft they placed disintegrated and the suprarenal stent separated from the main body graft and the patient expired.¿ the patient had a tffb-26-125-zt implanted on (b)(6) 2016.It was reported that the suprarenal stents of the tffb-26-125-zt separated, resulting in the patient's aneurysm rupturing.Consequently, the patient died.On (b)(6) 2020, the patient presented to the emergency department as symptomatic with both back and abdominal pain.Ct imaging showed separation of the suprarenal stents, graft disintegration, and an aneurysm rupture, so a secondary procedure was completed in which a competitor thoracic graft was implanted.Ballooning was done in all seal zones.The issue temporarily resolved after the secondary procedure, but the patient passed "some time after" due to complications from the aneurysm rupture.The patient did not have any calcification and had "very minimal" a-p angulation in the proximal seal zone.Aneurysm growth was observed into the proximal seal zone as well as in the main aaa sac.Due to the patient's chronic kidney disease, contrasted ctas were unable to be performed during follow-ups.A non-contrasted cta was done on (b)(6) 2018 and a "us" was performed in 2017.A "screening us" was planned for 2020, but it appears that the "patient missed 2019".The patient was on "asa 81mg daily, statin and bp meds" before/after the procedure.A review of documentation including the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions (mi), quality control and specifications, as well as inspection of imaging of the device, was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, imaging (ct scans) was provided by the user facility and submitted for expert image review.Findings of the imaging review included that there is significant diameter discrepancy between the suprarenal stent and the first sealing stent at 30 months post-implantation.At 44 months post-implantation, complete separation of these components was observed with retraction of the proximal graft into the aaa sac.There was notable severe reverse tapered anatomy of the infrarenal neck combined with circumferential mural thrombus throughout the proximal neck.The proximal graft and first sealing stent have uniformly expanded to match the distal neck diameter.At 44 months post-implantation, continued growth of the aaa sac with eventual rupture was observed.Evidence available at this time supports that the device was manufactured to specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file found that this product is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot (5966965) as well as the related component sub-assembly lots revealed no relevant non-conformances.A database search found this to be the only event associated with the reported device lot.It should be noted that tffb devices are distributed via one-device lots.As there are adequate inspection activities in place, objective evidence that the dhr was fully executed, no related non-conformances, and no other lot-related complaints received from the field, cook has concluded that there is no evidence that non-conforming product exists in house or in field.Cook also reviewed product labeling.The product instructions for use (ifu) ¿zenith flex aaa endovascular graft with the z-trak introduction system¿ states the following in consideration of 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: with a length of at least 15mm, with a diameter measured outer wall to outer wall of no greater than 32mm and no less than 18mm, with an angle less than 60 degrees relative to the long axis of the aneurysm, and 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)." 5.2 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," ¿endoprosthesis: improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; perigraft flow; barb separation and corrosion.¿ 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: aneurysms with type i endoleak.Aneurysms with type iii endoleak.Aneurysm enlargement, =5mm of maximum diameter (regardless of endoleak status).Migration, 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 product returned, and the results of the investigation, a definitive root cause was traced to patient condition.The imaging suggests that use of the device outside of measurements indicated in the ifu (specifically infrarenal neck anatomy) as well as pre-existing thrombus are likely the cause of separation.It is possible that aggressive ballooning during the repair could have caused the partial separation of the graft material from the suprarenal stent and that continued hemodynamic forces/continued aortic disease progression led to complete component separation; however, this cannot be confirmed based on the imaging provided.Furthermore, the patient missed follow-up imaging in 2019, which could have potentially led to earlier intervention.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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.
Additional Manufacturer Narrative
This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Additional information regarding answered requested information was received on 20apr2020.The patient did not have any calcification and had "very minimal" a-p angulation in the proximal seal zone.Aneurysm growth was observed into the proximal seal zone as well as in the main aaa sac.Due to the patient's chronic kidney disease, contrasted ctas were unable to be performed during follow-ups.A non-contrasted cta was done on (b)(6) 2018 and a "us" was performed in 2017.A "screening us" was planned for 2020, but it appears that the "patient missed 2019".The patient was on "asa 81mg daily, statin and bp meds" before/after the procedure.

• 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: 9912404
• Report Number: 1820334-2020-00729
• Device Sequence Number: 19671874
• Product Code: MIH
• UDI-Device Identifier: 10827002484150
• UDI-Public: (01)10827002484150(17)170629(10)5966965
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2020

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: 06/29/2017
• Device Model Number: G48415
• Device Catalogue Number: TFFB-26-125-ZT
• Device Lot Number: 5966965
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 04/20/2020; 06/11/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 04/22/2020; 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GORE THORACIC GRAFT.; GORE THORACIC GRAFT.
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 70 YR