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

Model Number G42785

Device Problem Fluid/Blood Leak (1250)

Patient Problems Death (1802); Ischemia (1942); Paraplegia (2448); No Code Available (3191); Embolism/Embolus (4438); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/23/2018

Event Type  Death  

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 Description

It was reported that a study patient developed a type 1b endoleak following implantation of a zenith aaa endovascular graft aaa ancillary component main body extension.On (b)(6) 2017, a ct scan performed showed a stable, type iv thoracoabdominal aneurysm with mild iliac angulation.The patient's celiac, superior-mesenteric (sma), and right renal arteries were patent.The left renal artery was noted to be occluded.No renal infarcts were viewed.Patient measurements were recorded to be: maximum aneurysm diameter: 59 mm length from celiac to sma: 15 mm length from celiac to right renal: 40 mm length from celiac to left renal: 0 mm length from sma to right renal: 25 mm length from the lowest renal artery to start of the aneurysm (measured from distal-most aspect of renal artery): 0 mm.On (b)(6) 2018, three cook custom-made devices, the complaint device, and one competitor device were implanted without difficulties during an endovascular procedure.Post-procedural imaging revealed evidence of a type 1a endoleak, which is reported under mdr ref.#3002808486-2019-00778.No device integrity issues or technical abnormalities were noted.The patient was discharged on (b)(6) 2018.On (b)(6) 2018 (the day of discharge), a definitive paraplegia was discovered.At the 30-day follow-up on (b)(6) 2018, a ct scan revealed a maximum aneurysm diameter of 61 mm.The celiac artery, sma, and devices were patent.The right and left renal arties had lost patency.There was no evidence of separation of components, migration, or device integrity issues.A type 1b endoleak was discovered on the distal cuff, which is the subject of this report.On (b)(6) 2018, the patient had an event described as "rapid/general state deterioration" and was administered medication.The patient was said to have remained in this state until their death.On (b)(6) 2018, the patient had an event of distal embolization (cause unknown) with tissue loss and was admitted to the hospital for surgical transfemoral amputation of the leg due to leg ischemia and paraplegia.The leg ischemia/paraplegia was considered to be related to the index procedure due to coverage of the spinal cord arteries and is reported under mdr ref.#3002808486-2018-01036 and mdr ref.#3002808486-2019-00779.The patient was treated successfully.On (b)(6) 2018, the patient died due to "consequences of slip syndrome" related to the index procedure, "old age", and "paraplegia [leading] to transfemoral amputation".They had remained in the study up until their death.It was also reported that "bi-iliac treatment is dated of 2008, no information available".

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation - evaluation.On (b)(6) 2021, cook became aware of an incident where during a post-operative check-up, a type 1b endoleak was noted in a zenith aaa endovascular graft aaa ancillary component main body extension (rpn: (b)(4) lot: 8235300).The issue was reported by a physician at chu de toulouse in france.No device integrity issues or technical abnormalities were noted.A review of documentation including the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions (mi), and quality control, as well as a visual inspection of imaging, was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, though imaging was not provided to cook, ct scans were reviewed by the medical personnel at the reporting facility.Findings of that review indicated that on (b)(6) 2018, the maximum aneurysm diameter was 61 mm.The celiac and superior mesenteric arteries as well as the devices were patent, but the right and left renal arteries had lost patency.There was no evidence of separation of components, migration, or device integrity issues.A type 1b endoleak was revealed on the esbe device.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 (dhf) showed that this device is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot (8235300) and the related graft subassembly lot revealed no recorded non-conformances.A database search did not identify any other events associated with the reported device lot.It should be noted that this device is distributed via 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 ifu, t_eaaa36_rev3 ¿zenith aaa ancillary components,¿ provides the following information to the user related to the reported failure mode: ¿4 warnings and precautions 4.1 general additional endovascular interventions 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 or migration may lead to aneurysm rupture.4.2 patient selection, treatment and follow-up size of the pre-existing zenith aaa endovascular graft should be assessed before selecting a main body extension.4.5 implant procedure inaccurate placement and/or incomplete sealing of the zenith spiral-z aaa ancillary components within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the internal iliac arteries.5.2 potential adverse events adverse events that may occur and/or require intervention include, but are not limited to: endoleak endoprosthesis: improper component placement; incomplete component deployment; component migration; component separation from another graft component; suture break; occlusion; infection; stent fracture; graft material wear; dilation; erosion; puncture; perigraft flow; and corrosion 12.1 general 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.12.3 additional surveillance and treatment additional surveillance and possible treatment is recommended for: aneurysm enlargement, = 5 mm of maximum diameter (regardless of endoleak status)¿.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be determined.However, it should be noted that endoleaks are a known inherent risk of using this device.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.

• Brand Name: ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11385781
• MDR Text Key: 233797967
• Report Number: 1820334-2021-00393
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002427850
• UDI-Public: (01)10827002427850(17)190928(10)8235300
• Combination Product (y/n): N
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: G42785
• Device Catalogue Number: ESBE-26-58
• Device Lot Number: 8235300
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 03/22/2021
• Supplement Dates FDA Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK: FEN-THORACO-ABDOMINAL-GRAFT; COOK: ZTA-P-34-113; COOK: ZTA-PT-38-34-167; NON-COOK: BGP37072, RENAL STENT, RIGHT; COOK: FEN-THORACO-ABDOMINAL-GRAFT; COOK: ZTA-P-34-113; COOK: ZTA-PT-38-34-167; NON-COOK: BGP37072, RENAL STENT, RIGHT
• Patient Outcome(s): Death
• Patient Age: 71 YR
• Patient Weight: 85