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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

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WILLIAM COOK EUROPE ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Catalog Number ZTA-PT-38-34-167-W1
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Vascular Dissection (3160)
Event Date 03/05/2024
Event Type  Injury  
Manufacturer Narrative
Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.G4) similar to device under pma/510(k)p140016 investigation is still in progress.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 Description
Description of event according to initial reporter: patient anatomy before surgery and at the time of failure (access route): the left eia (external iliac artery) has calcification, and the smallest blood vessel diameter is 6.1mm.The right eia (external iliac artery) bare stent placed, tortuosity, minimum vessel diameter is 5mm.In a meeting with the physician the day before the surgery, it was determined that although it was difficult to determine whether the left side was better or worse, the left side was more likely, so the plan was to try the left side, and if that didn't work, then the right side.Range of anatomical indications: outside of anatomical indications the patient was 82 years old and had a history of open chest and abdominal surgery.Because the lesion was in the descending aorta, we decided to attempt thoracic endovascular aortic repair (tevar), considering the invasiveness of the surgical procedure and the fact that access might be difficult, but with the intention of withdrawing if delivery was not possible.A dummy trial was performed using gore/dryseal 18fr from the left femoral artery.The inner cannula (6.1mm) alone passed through eia, but the one with the outer cannula (6.7mm) did not.We performed pta (percutaneous transluminal angioplasty) on eia using an 8mm balloon and tried again with an outer cannula and confirmed that it passed.Therefore, we delivered zta-pt-38-34-167-w1 (7.1mm/lot# e4400227), but it could not pass through eia.Pta was attempted again, but the difference between the inner and outer cannula got caught in the calcification and delivery was not possible, so the approach was changed to from the right femoral artery.After performing pta on the right femoral artery and confirming that gore/dryseal 18fr passed through eia, zta-pt-38-34-167-w1 (lot# e4400227) was delivered, but the fray at the difference between the inner and outer cannula got caught on the indwelling bare stent and did not advance.However, the gore/dryseal had seemed to pass more smoothly than the left side, and the physician's feeling in his hand also determined that it could be delivered from the right side with less resistance than the left side.The physician shaved off the frayed part of the sheath and tried again, but the coating had peeled off and the sheath was also kinked.There was also a difference in the sheath part, which prevented the insertion force from being transmitted properly, and it was determined that trying again with zta-pt-38-34-167-w1 (lot# e4400227) would increase the risk of blood vessel damage, making delivery difficult.We replaced the device with zta-pt-38-34-167-w1 (lot# e4473009), performed delivery, and confirmed that it passed through eia.Tevar was performed according to the original plan.No endoleak was identified on final angiography and tevar was completed.Access angiography revealed dissection in the left eia, which was occurred as a result of delivery of zta-pt-38-34-167-w1 (e4400227), and boston scientific/epic (self-expanding nitinol stent system, f8mm-8cm) was placed and the procedure was completed.Additional information received 08mar2024: dissection of the left eia was not confirmed when angiography was performed to confirm access after balloon dilation (pta), so it is thought that it occurred when zenith was delivered.The flow of the procedure was as follows: gore/dryseal 18fr with the outer cannula (6.7mm) did not pass through the left eia pta gore/dryseal 18fr could pass through zta-pt-38-34-167-w1 (e4400227) did not pass through pta & angiography (at this point, dissection was not confirmed) zta-pt-38-34-167-w1 (e4400227) did not pass through again the access site was changed to the right femoral artery.The device was changed to zta-pt-38-34-167-w1 (e4473009) halfway and tevar was performed.Angiography confirmed no endoleak access angiography revealed dissection in the left eia boston scientific/epic was deployed.Patient outcome: no adverse effect on the patient has been reported.
 
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Brand Name
ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS
Type of Device
MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA  4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA   4632
Manufacturer Contact
alex rahbek
sandet 6
bjaeverskov 4632
DA   4632
56868686
MDR Report Key18892752
MDR Text Key337512591
Report Number3002808486-2024-00045
Device Sequence Number1
Product Code MIH
UDI-Device Identifier10827002448664
UDI-Public(01)10827002448664(17)260428(10)E4400227
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial
Report Date 03/13/2024
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 Catalogue NumberZTA-PT-38-34-167-W1
Device Lot NumberE4400227
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/05/2024
Initial Date FDA Received03/13/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/28/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age82 YR
Patient SexMale
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