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-36-113-W1

Device Problems Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Similar to device marketed under pma/510(k): p140016.Investigation is still in progress.

Event Description

Description of event according to initial reporter: a (b)(6) male patient underwent tevar to treat the thoracic saccular aneurysm by left approach on (b)(6) 2021.The length of the target site was short which was approximately 100mm, so zta-p-36-113-w1 was selected.The aorta was not tortuous and also there was no problem observed in the vessel diameter of the access route.The patient was suitable for the procedure.When the physician inserted the delivery system, he slighlty felt resistance as if it was rubbing something.The resistance became stronger when he continued to advance the delivery system, so he removed it from the patient and confirmed deformation of the sheath tip outside the patient.There was another zta-p-36-113-w1 as a back-up device, so it was used instead.The back-up device could be placed to cover the target length successfully.Final angiography was performed to check the access route and no damage was confirmed, so the procedure was finished without any additional treatment.Patient outcome: there have been no adverse effects to the patient reported.The patient recovered.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: a 78-year-old male patient with the thoracic saccular aneurism underwent thoracic endovascular repair (b)(6) 2021.The length of the target site was short, so zta-p-36-113-w1 (complaint device) was selected.It was reported that the aorta was not tortuous and the access vessels was without calcification and with an appropriate diameter.When the physician inserted the delivery system, he felt slight resistance as if it was rubbing something.The resistance became stronger when he continued to advance the device, so he removed it from the patient and saw deformation of the sheath tip.The procedure was completed with a back-up device zta-p-36-113-w1.Final angiography was performed to check the access route.No damage was confirmed, so the procedure was finished without any additional treatment.No adverse effects to the patient have been reported.Three photos of the device were provided for the investigation.On the photos, the zta device is presented on an operating table beside another device.2 photos show the proximal end of the devices and the 3rd photo shows the labels on the sheath.On the photos of the tip there appears to be a slight deformation of the sheath tip.A planning sizing document was provided showing that the minimum diameter in the access vessels is 8.7 mm.Review of the device history record gave no indication of the product being produced out of specification.The instructions for use valid for this device states that the device should be inspected to verify that no damages has occured before using the device.Based on the reported information, it has not been possible to establish an exact cause for this event.It is possible that the damage on the sheath tip occurred when the device was inserted into the patient anatomy and resistance was felt.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.

• 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: 11336821
• MDR Text Key: 240666982
• Report Number: 3002808486-2021-00125
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002449562
• UDI-Public: (01)10827002449562(17)230319(10)E3965055
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2023
• Device Catalogue Number: ZTA-P-36-113-W1
• Device Lot Number: E3965055
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 03/05/2021
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1