MAUDE Adverse Event Report: COOK INC ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G55235
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Occupation: supervisor.(b)(4).The patient required a blood transfusion and retroperitoneal hematoma drainage as a result of this event.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 zenith flex with spiral-z technology aaa endovascular graft iliac leg was torn and thus observed leaking following implantation.The device was implanted through the patient's left external iliac artery along with another leg graft.Following implantation, a balloon was used to "leverage the union" between the grafts.Contrast injection was then performed, which revealed a type 3b endoleak.Ballooning was repeated and followed by more contrast injection, which showed persistence of the endoleak.Injections were then performed with the "arch oblique", but the leak still persisted.It was then concluded that there was a tear within the graft fabric.The graft was left implanted in the patient, though another extension graft was placed.The patient required a blood transfusion and retroperitoneal hematoma drainage as a result of this event.Additional information regarding the patient, device, and event has been requested but is currently unavailable.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Additional information: b5, d11.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
It was reported in additional information received on 06jul2020, that the problem with this device is that the fabric of the zsle-13-122 has a hole through which the leak occurred.This occurred during the re-intervention, in which the area rep was present for the case.A coda balloon was used and the inflation volume was 15cc.The graft was ballooned at the connection of the two extensions, sealing zone.The iliac extension was placed during the re-intervention for the type 3 endoleak.The retroperitoneal hematoma drainage and transfusion were performed as a result of the type 3 endoleak bleeding.The patient was taking enoxaparine and asa for anti-coagulation therapy.The patient did have some tortuosity, but did not have calcification.The patient was released in good condition.
Event or Problem Description
During the investigation for this complaint, it was discovered that the failure mode was a type 1b endoleak, not a type 3b endoleak, as previously reported.The type 1b endoleak resulted in a aneurysm rupture requiring a surgical intervention for drainage of a retroperitoneal hematoma and an evar to extend the iliac leg graft to address the rupture.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Additional information: section c correction: b5 h6 ¿ additional method code - device not accessible for testing (4117) investigation ¿ evaluation cook was informed on (b)(6) 2020 of an incident involving a zenith flex with spiral-z technology aaa endovascular graft iliac leg (zsle-13-122-zt) from lot 10282946.An endoleak was noted in the complaint device during a follow-up evar procedure to resolve an endoleak on (b)(6) 2020.Communication with the user facility clarified that standard ballooning techniques were used to implant the device and that some tortuosity was noted.The patient reportedly experienced no adverse effects as a result of this incident, no additional harm was reported.A review of documentation including the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection of post-implant ct imaging, was conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examinations were conducted.However, post-implant ct imaging was provided to aid in the investigation.The image reviewer confirmed a type 3b endoleak in an unconfirmed zsle and a type 1b endoleak on a zsle-13-122-zt.The reviewer asserts that the cause of the type 3b endoleak can be attributed to increased arterial pressure, caused by the injection of contrast, exacerbating a suture hole as well as the anticoagulation of the patient¿s blood.Cook has concluded that the device was manufactured to specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file (dhf) found that the affected product is safe and effective for its intended use.A review of the device history record (dhr) for lot 10282946 found no nonconformances that could have contributed to the reported failure mode.It should be noted that there were no additional complaints associated with this lot and that zsle devices are distributed via one-device lots.Because 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 have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field.Cook also reviewed product labeling.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: "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.- patients experiencing reduced blood flow through the graft limb and/or leaks may be required to undergo secondary interventions or surgical procedures.5.2 potential adverse events adverse events that may occur and/or require intervention include, but are not limited to: - endoleak - endoprosthesis: graft material wear; erosion; puncture.11.1 zenith spiral-z aaa iliac leg system 11.1.7 molding balloon insertion 5.Expand the molding balloon with diluted contrast media (as directed by the manufacturer) in the area of the most proximal covered stent and the infrarenal neck, starting proximally and working in the distal direction.6.Withdraw the molding balloon to the ipsilateral limb overlap region and expand.7.Withdraw the molding balloon to the ipsilateral distal fixation site and expand.8.Deflate and remove molding balloon.Transfer molding balloon onto the contralateral wire guide and into the contralateral iliac leg introduction system.Advance molding balloon to the contralateral limb overlap and expand.9.Withdraw the molding balloon to the contralateral iliac leg/vessel distal fixation site and expand.Final angiogram 1.Position angiographic catheter just above the level of the renal arteries.Perform angiography to verify that the renal arteries are patent and that there are no endoleaks.Verify patency of internal iliac arteries.2.Confirm there are no endoleaks or kinks and verify position of proximal gold radiopaque markers.Remove the sheaths, wires and catheters.Note: if endoleaks or other problems are observed, refer to the suggested instructions for use for the zenith aaa endovascular graft ancillary components.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." based on the information provided, examination of provided imaging, and the results of our investigation, a definitive cause for the failure could not be established.However, it should be noted that endoleaks are a known inherent risk of using these devices.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We 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 SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10227786
• Report Number: 1820334-2020-01248
• Device Sequence Number: 3142977
• Product Code: MIH
• UDI-Device Identifier: 10827002552354
• UDI-Public: (01)10827002552354(17)230124(10)10282946
• Combination Product (Y/N): N
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/29/2020

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: 01/24/2023
• Device Model Number: G55235
• Device Catalogue Number: ZSLE-13-122-ZT
• Device Lot Number: 10282946
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/06/2020; 12/09/2020
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 08/03/2020; 12/29/2020
• 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: CODA BALLOON; LUNDERQUIST, ZSLE-11-122-ZT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 65