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

Model Number	G19172
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Expiration date: the lot number for this device was manufactured prior to the current system.The exact expiration date is unknown.Concomitant medical products: cook products: tfle-18-54, tfle-16-71, non-cook products: medtronic 28mm endocuff, gore viabahn endoprosthesis (qty 2), abbott pta balloons, endoanchors.(b)(6).Manufacture date: the lot number for this device was manufactured prior to the current system.The exact manufacture date is unknown.(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 suprarenal stent of a zenith flex aaa endovascular graft bifurcated main body separated from the seal stent.As a result, the patient developed a type ia endoleak.The surgeon "performed a chimney procedure by putting in bridging stent grafts into both renals to fix the endoleak".The device remains in the patient.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.D4- product lot #: suspected to be 2038919.H6 - method code: device not accessible for testing (4117).Investigation - evaluation.The complainant, (b)(6) located in australia, informed cook on (b)(6) 2019 of an incident involving a zenith flex aaa endovascular graft bifurcated main body with rpn tffb-24-111 from the reported lot u2038919.An initial endovascular aortic repair (evar) procedure was completed in 2008 on a 78-year-old male patient.Three cook devices, a main body graft (complaint device) and two iliac leg grafts, were implanted.Sometime after the initial procedure, it was reported that a type 1a endoleak occurred due to separation of the suprarenal stent from the graft.An additional intervention was performed on (b)(6) 2019.The surgeon performed a ¿chimney procedure¿ by placing a competitor endocuff between the separated graft and suprarenal stent and placing two competitor endografts in the renal arteries.The physician reported that if the endoleak persisted after the post-procedure scan or ultrasound, he will take further steps to treat the patient.A review of the complaint history, device history record (dhr), drawing, instructions for use (ifu), quality control and specifications, as well as a review 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 of the device including cta and angiography scans were provided by the user facility and sent for expert image review.Findings of the image review noted the separation between the sealing stent and the suprarenal stents (excluding the right posterior sutures), creating a 13 mm gap.Contrast flow through this gap was consistent with a type 1a endoleak.The image reviewer observed two findings that are common in similar cases.First, the aneurysm growth appeared to engulf the sealing stent, placing heavy stress on the suprarenal stent graft sutures.Second, the left iliac leg outflow appeared impeded by a meniscus-shaped partial obstruction.Over time, these repeated stresses could wear down and deteriorate the sutures, causing the suprarenal stent to separate from the graft.As a result, the seal zone was extended and additional grafts were implanted.Following the secondary procedure, the endoleak persisted/did not resolve.Based on the evidence provided and observed, cook has concluded that the device was manufactured to current specifications.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient controls and inspections are in place to prevent the release of non-conforming product related to the reported failure mode.A review of the design history file found that this product is both safe and effective for its intended use.The reported device lot, u2038919, was not consistent with the reported device rpn.However, with removing the "u" prefix, lot 2038919 is consistent with the reported device and was shipped to a customer in australia in 2008 (consistent with the complaint device's implant year).A review of the dhrs for lot 2038919 and the related graft component lots revealed no non-conformances.It should be noted that tffb is a one-device lot.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 the field.Cook also reviewed product labeling.The product instructions for use (ifu), ¿zenith flex® aaa endovascular graft with the h&l-b one-shot¿ introduction system¿, provides the following information to the user related to the reported failure mode: ¿4 warnings and precautions 4.1 general.The long-term performance of endovascular grafts has not yet been established.All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms 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.After endovascular graft placement, patients should be regularly monitored for perigraft flow, aneurysm growth or changes in the structure or position of the endovascular graft.At a minimum, annual imaging is required, including: 1) abdominal radiographs to examine device integrity (separation between components, stent fracture or barb separation) and 2) contrast and non-contrast ct to examine aneurysm changes, perigraft flow, patency, tortuosity and progressive disease.If renal complications or other factors preclude the use of image contrast media, abdominal radiographs and duplex ultrasound may provide similar information.Intervention or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing enlarging aneurysms, unacceptable decrease in fixation length (vessel and component overlap) and/or endoleak.An increase in aneurysm size and/or persistent endoleak may lead to aneurysm rupture.Patients experiencing reduced blood flow through the graft limb and/or leaks may be required to undergo secondary interventions or surgical procedures.4.2 patient selection, treatment and follow-up.Key anatomic 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 (<15 mm); an inverted funnel shape (greater than 10% increase in diameter over 15 mm 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.Irregular calcification and/or plaque may compromise the fixation and sealing of the implantation sites.Necks exhibiting these key anatomic elements may be more conducive to graft migration.5 adverse events 5.2 potential adverse events adverse events that may occur and/or require intervention include, but are not limited to: aneurysm enlargement.Endoleak.Endoprosthesis: suture break; occlusion graft material wear.Occlusion of device or native vessel.8 patient counseling information.Device related risks include occlusion, endoleak, aneurysm enlargement, fracture, potential for reintervention and open surgical conversion, rupture and death.12 imaging guidelines and postoperative follow-up 12.1 general the long-term performance of endovascular grafts has not yet been established.All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive additional follow-up.Physicians should evaluate patients on an individual basis and prescribe their follow-up relative to the needs and circumstances of each individual patient.The recommended imaging schedule is presented in table 12.1.This schedule continues to be the minimum requirement for patient follow-up and should be maintained even in the absence of clinical symptoms (e.G., pain, numbness, weakness).Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the stent graft) should receive follow-up at more frequent intervals.12.6 additional surveillance and treatment additional surveillance and possible treatment is recommended for: aneurysms with type i endoleak.Aneurysm enlargement, =5 mm of maximum diameter (regardless of endoleak status).Migration¿ based on the information provided, no product returned, and the results of the investigation, a root cause was traced to patient condition.One possible cause is that aneurysm growth over time pulled the suprarenal stent and wore down the sutures.Another possible cause is that the repeated impact from flow against the partially obstructed left iliac leg graft over time stressed the suprarenal stent sutures and eventually deteriorated them.No information was provided about the frequency of patient follow-ups, which may have detected the separation earlier.Additionally, device migration and endoleaks are both known inherent risks of using tffb devices.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 9249433
• Report Number: 1820334-2019-02707
• Device Sequence Number: 14031136
• Product Code: MIH
• UDI-Device Identifier: 00827002191723
• UDI-Public: (01)00827002191723(17)140201(10)U2038919
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2020

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 Model Number: G19172
• Device Catalogue Number: TFFB-24-111
• Device Lot Number: U2038919
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 05/04/2020
• 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: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR