MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G47444
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref# (b)(4) pma/510(k): p180001.Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: the patient was being treated for aaa on (b)(6) 2021.The concern was that the patient had very narrow and calcified vessels throughout.The initial part of procedure was to dilate up the vessels.They used 14, 16, 18, 20 and 22 fr dilators that passed with some resistance but were able to pass.The physician decided to try this device and in doing so was not able to pass it much past the common iliac.While doing that, the patient became slightly unstable.So, he removed the device and put up a 32 coda balloon and inflated it to determine if there were any ruptures of the vessel.He stabilized the patient and did not notice any leaks or ruptures initially.He then placed a gore abdominal device to treat the upper area.When finished on the same side that our device went up, he withdrew the sheath back and did another angio run.He then observed a small external iliac rupture which he proceeded to fix with gore viabonds to cover it.It could not be determined exactly what caused the small rupture.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Summary of investigational findings: a male patient of unknown age underwent evar (abdominal endovascular aneurysm repair) for aaa (abdominal aortic aneurysm).As per reported event the significant calcified access vessels were dilated before inserting a zdeg-p-28-82-pf-us device but resistance was met at the common iliac artery.During implantation of the zdeg-p-28-82-pf-us device the patient became unstable and the zdeg-p-28-82-pf-us device was removed, and the patient was successfully stabilised.Subsequently a gore device was inserted through the same access vessel and the device was advanced successfully to the target site.A post-op angiogram was performed and revealed a small external iliac rupture that was repaired with gore viabonds.The physician has not been able to determine the cause for the small iliac rupture.Review of the device history record gave no indication of the device being produced out of specifications.Based on the reported information the exact cause for this event could not be established.As the access vessel was dilated up from 14fr to 22fr and the introduction system of the zdeg-p-28-82-pf-us is 20 fr, it is possible that the device was oversized for the access vessel.It is likely that patient anatomy with a narrow significant calcified vessel combined with the choice of using an oversized device could be the cause for this event.Per the ifu ilio-femoral access vessel size and morphology (thrombus, calcification and/ or tortuosity) should be compatible with vascular access techniques and introduction system.Cook will reopen the investigation if further information becomes available.Cook medical will continue to monitor for similar events.This report is required by the fda under 21cfr 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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 11523494
• Report Number: 3002808486-2021-00976
• Device Sequence Number: 14445992
• Product Code: MIH
• UDI-Device Identifier: 10827002474441
• UDI-Public: (01)10827002474441(17)230310(10)E3960830
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2021

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: 03/10/2023
• Device Model Number: G47444
• Device Catalogue Number: ZDEG-P-28-82-PF-US
• Device Lot Number: E3960830
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 07/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1