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

Catalog Number ZTA-D-38-197-W1

Device Problems Difficult or Delayed Activation (2577); Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 11/17/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Similar to device marketed 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: a patient underwent tevar to treat taa.The patient's anatomical form was suitable for endovascular repair.The physician advanced the delivery system of zta-d-38-197-w1 from the right femoral and deployed the stent graft at right above the sma as planned.However the distal bare stent would not open even he operated as instructed.The trigger wires were adequately rolled up to the point of stop as instructed as well.The rep was not attended at the procedure but was talking with the user on the phone at this time and he suspected that the distal bare stent was caught in the bottom cap.So he suggested moving the gray positioner and adding tension over entire delivery system, but the physician did not do that willingly because the target site was right above the sma.Then the physician used a balloon catheter to add tension, and during doing that, the distal bare stent became released from the delivery system.However the stent graft covered half of the sma.The physician tried to canulate the sma to place a stent in the sma but did not succeed, so the procedure converted to open surgery.Patient outcome: the patient has not shown any problematic symptoms due to conversion to open surgery.Although, there is no information about what treatment was done during the open surgery as of today.

Event Description

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

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: a patient underwent tevar (thoracic endovascular aortic repair) to treat taa (thoracic aortic aneurysm).The patient's anatomical form was reported to be suitable for endovascular repair.The physician advanced the delivery system of zta-d-38-197-w1 (complaint device) from the right femoral and deployed the stent graft at right above the sma (superior mesenteric artery) as planned.The coeliac artery was planned to be covered.However, the distal bare stent would not open even he operated as instructed.The trigger wires were adequately rolled up to the point of stop as instructed as well.The rep suspected that the distal bare stent was caught in the bottom cap and suggested moving the gray positioner and adding tension over entire delivery system.The physician did not do that willingly as the target site was right above the sma.The physician used a balloon catheter to add tension, and during doing that, the distal bare stent became released from the delivery system.However, the stent graft covered half of the sma (superior mesenteric artery).The physician tried to cannulate the sma to place a stent in the sma, but failed, so the procedure was converted to open surgery.No information about what treatment was done during the open surgery was provided but no problematic symptoms were observed caused by the conversion to open surgery.Per the instruction for use, if the bare stent cannot be fully deployed from the cap, advance the flexor sheath to the distal edge of the stent graft.Stabilize the flexor sheath and pull back the blue rotation handle.The bare stent will now be released from the cap but still be inside the sheath.Withdraw the sheath slowly with a rotating movement until the bare stent is outside the sheath.The complaint device was returned and evaluated.The device evaluation identified several minor scratches on the inner side of the bottom cap.It is possible that these scratches caused the resistance during retraction.The device evaluation identified the burr in the wire hole on the inner side of the bottom cap, which can indicate that a barb got stuck in the bottom cap and possibly contributed to deployment difficulties.An initial action was previously initiated to address difficulties with releasing the distal end of zta-d stent graft and is still in progress.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 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.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL 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, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 15913476
• MDR Text Key: 304783287
• Report Number: 3002808486-2022-01042
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002448879
• UDI-Public: (01)10827002448879(17)251010(10)E4314729
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

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 Number: ZTA-D-38-197-W1
• Device Lot Number: E4314729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 02/28/2023
• Supplement Dates FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention