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	N/A
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 gold marker of a zenith flex with spiral-z technology aaa endovascular graft iliac leg was misplaced.No difficulty was experienced deploying the device.Following deployment in the patient's left common iliac artery (to be used as the contralateral limb extension), the physician noticed that the device's gold marker appeared to be lower than expected in relation to the top seal stent (visualized approximately 13-15mm below via intra-operative ct imaging).As a result, the graft was deployed higher than expected, resulting in the need for an additional limb to be placed on the ipsilateral side to "match the overlap".Additionally, an endoleak (type currently unknown) was noted following device placement, presumably occurring as a result of this event.The patient was able to return home at the "expected time" of the day following surgery and is currently awaiting their 30-day post-op ct scan.No secondary procedures have currently been performed and no other adverse effects have been reported.
Event or Problem Description
Additional information was received on 20apr2021.With the balloon in one of the limbs, it was noted that this limb has "nearly an entire stent cephalad to the matching limb", despite the gold markers matching up "on each deployment".The physician confirmed this by inflating a coda balloon from the right side just cephalad to the right limb.The balloon was expanded to its capacity and an entire stent of the left limb was next to it.At this point, the physician realized that there was an issue.After the additional right limb was placed, the limbs were matched up proximally; distally, the new limb was one stent higher than the original one.Gold markers were lined up "with each deployment", indicating that the original limbs were not deployed incorrectly.
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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Correction: during the investigation, a review of intra-operative imaging of the implanted graft assembly was performed.The imaging suggested that the gold marker of the device was in the correct and intended location, as the ipsilateral and contralateral legs are aligned and the markers are aligned.Based on this information along with a review of quality control documents, there is no evidence suggesting the device was nonconforming/manufactured out of specification.Additionally, the letter from the fda on (b)(6) 2004 states that events describing proximal and distal endoleaks associated with device placement would not be reportable if they occur during surgery and can be successfully corrected by troubleshooting techniques as per the device labeling.As the endoleak that occurred was able to be resolved within the same procedure via additional device placement, which is a troubleshooting technique according to device labeling, this event no longer meets the qualifications for a reportable event.As such, no further reports regarding this event will be submitted.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
This event no longer meets the qualifications for a reportable event.See h10.

• 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 11657647
• Report Number: 1820334-2021-01129
• Device Sequence Number: 3606282
• Product Code: MIH
• UDI-Device Identifier: 10827002552460
• UDI-Public: (01)10827002552460(17)240202(10)13727329
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/02/2024
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-24-74-ZT
• Device Lot Number: 13727329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 04/20/2021; 11/11/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 04/26/2021; 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CODA BALLOON
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male