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

Catalog Number ZTA-P-42-225-W1

Device Problem Failure to Advance (2524)

Patient Problem Tissue Damage (2104)

Event Date 04/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device is similar to device under 510(k) p140016.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: a male patient underwent taa repair.The average size of the access vessel was 7.5 mm.The aorta was strongly tortuous at the level of the diaphragm.The taa was the large saccular aneurysm located at the greater curvature of the aorta arch.After performing 2 debranch, zta-p-40-217-w1 was inserted from the right femoral artery and the stent graft was placed.(update added 16apr2018): the stent graft's proximal side was placed at the origin of the aneurysm and the distal side was placed at the proximal of the strongly tortuous part at the level of the diaphragm.Then the physician inserted zta-p-42-225-w1 to deploy the stent graft proximally to the first one.However, the tip of the delivery system got caught in the proximal side of the first one and became unable to advance any further.There was no way to advance it to the target site, so he replaced it with gore's c-tag.He inserted gore's 24fr dryseal flex sheath and inserted the c-tag into it and the c-tag could be advanced and the stent graft was placed successfully, but the damage of the vessel was confirmed by angiography after the delivery system of the c-tag was removed.He placed gore's excluder legs to repair the vessel damage.Arrest of bleeding was confirmed and the procedure was completed.Additional information provided on 19apr2018: the damage area of the vessel was the right common iliac artery to the right external iliac artery and the physician thinks the cause of the damage was insertion of gore's 24fr dryseal flex sheath into the small vessel in order to insert the c-tag.Patient outcome: no adverse effects on the patient due to this occurrence was reported as of today.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi).400 daniels way.Bloomington, in 47404.Registration no.: 3005580113.H6) ec method code: 4109 - historical data analysis.4112 - imaging.4114 - device not returned.Summary of investigational findings: according to the reported information, the complaint device (zta-p-42-225-w1) was removed from the patient due to difficulties with advancing the device past the previously inserted zta device.Instead a gore 24fr sheath was inserted, and following a gore device was inserted and placed in the patient.After removal of the gore delivery system, angiography confirmed vessel damage, which was repaired.Subsequently arrest of bleeding was confirmed and the procedure completed.The average size of the access vessel was reported to be 7.5mm.According to additional information, the physician thinks the cause of the damage may possibly have been insertion of gore's 24fr sheath into the small vessel.The imaging review states that the complaint of iliac artery rupture cannot be confirmed as no imaging from the procedure was provided.The review notes that right iliac artery tortuosity was mild and that the right external iliac artery lumen diameter was 5.5mm near the inguinal ligament and 6.5mm at its midpoint.In comparison, the outer diameter of the complaint device sheath is 7.7 mm (refer to table 1 in ifu).The review notes that, although the external iliac artery lumen diameter was small enough to be ruptured by either the zta-p or gore sheath, the complaint report indicated that the larger gore sheath was responsible, which was likely based on clinical observations.However, this cannot be confirmed based on the provided information.The cause of the iliac rupture is possibly related to inadequate vessel diameter compared to the outer diameter of the introduction system.According to the ifu, the zenith alpha thoracic endovascular graft is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair, including iliac/femoral anatomy that is suitable for access with the required introduction systems.Adequate iliac or femoral access is required to introduce the device into the vasculature.Careful evaluation of vessel size, anatomy, and disease state is required to ensure successful sheath introduction and subsequent withdrawal, as vessels that are significantly calcified, occlusive, tortuous, or thrombus lined may preclude introduction of the endovascular graft and/or increase the risk of embolization.Vessel damage and bleeding are listed as potential adverse events in the ifu.No evidence to suggest that the product was not manufactured according to specifications.Cook medical will continue to monitor for similar events.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: a male patient underwent taa repair.The average size of the access vessel was 7.5mm.The aorta was strongly tortuous at the level of the diaphragm.The taa was the large saccular aneurysm located at the greater curvature of the aorta arch.After performing 2 debranch, zta-p-40-217-w1 was inserted from the right femoral artery and the stent graft was placed.(update added 16apr2018): the stent graft's proximal side was placed at the origin of the aneurysm and the distal side was placed at the proximal of the strongly tortuous part at the level of the diaphragm.Then the physician inserted zta-p-42-225-w1 to deploy the stent graft proximally to the first one.However, the tip of the delivery system got caught in the proximal side of the first one and became unable to advance any further.There was no way to advance it to the target site, so he replaced it with gore's c-tag.He inserted gore's 24fr dryseal flex sheath and inserted the c-tag into it and the c-tag could be advanced and the stent graft was placed successfully, but the damage of the vessel was confirmed by angiography after the delivery system of the c-tag was removed.He placed gore's excluder legs to repair the vessel damage.Arrest of bleeding was confirmed and the procedure was completed.Additional information provided on 19apr2018: the damage area of the vessel was the right common iliac artery to the right external iliac artery and the physician thinks the cause of the damage was insertion of gore's 24fr dryseal flex sheath into the small vessel in order to insert the c-tag.Patient outcome: no adverse effects on the patient due to this occurrence was reported as of today.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 7482249
• MDR Text Key: 107963420
• Report Number: 3002808486-2018-00504
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002449715
• UDI-Public: (01)10827002449715(17)201221(10)E3667919
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/07/2018

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: 12/21/2020
• Device Catalogue Number: ZTA-P-42-225-W1
• Device Lot Number: E3667919
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/13/2018
• Device Age: 4 MO
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 05/03/2018
• Supplement Dates Manufacturer Received: 07/23/2018
• Supplement Dates FDA Received: 08/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention