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-46-125-W1

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(4).(b)(6).Similar to device under 510(k) p140016.Investigation is still in progress.

Event Description

Description of event according to initial reporter: an (b)(6) year old male patient underwent taa repair.There was no notable anatomy problem.The physician placed zta-d-38-197-w1 first in the distal side of the descending aorta.Then he let zta-46-125-w1 expanded proximal to zta-d-38-197-w1 and then he turn the blue rotation handle to release the trigger wires and 'pro-form tie' to let the uncovered stent and proximal end of the graft open.However the uncovered stent and proximal end of the graft were deployed bent at 90 degrees.He managed to fix the bent using a balloon catheter carefully to complete the procedure.To be safe, unscheduled ct was conducted after the procedure to confirm if there was no damage in the aorta.Patient outcome: the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Summary of investigational findings: it is reported in this complaint file that the uncovered stent and proximal graft of the complaint device were deployed bent at a 90 degree angle.The product was not returned, but three videos recorded with a phone from an angiography monitor are provided.The imaging review confirms that the uncovered stent and the sealing stent tipped 90 degrees towards the inner aortic curvature.As per the reported information, this issue was corrected using ballooning and did not result in adverse effects to the patient.The performed investigation did not reveal any failures relating to deployment or manufacturing of the product and it was not possible to determine the possible cause of this event.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: an (b)(6) year old male patient underwent taa repair.There was no notable anatomy problem.The physician placed zta-d-38-197-w1 first in the distal side of the descending aorta.Then he let zta-46-125-w1 expanded proximal to zta-d-38-197-w1 and then he turn the blue rotation handle to release the trigger wires and 'pro-form tie' to let the uncovered stent and proximal end of the graft open.However the uncovered stent and proximal end of the graft were deployed bent at 90 degrees.He managed to fix the bent using a balloon catheter carefully to complete the procedure.To be safe, unscheduled ct was conducted after the procedure to confirm if there was no damage in the aorta.Patient outcome: the patient did not experience any adverse effects due to this occurrence.

• 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
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov DK-46 32; DA DK-4632
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 7395045
• MDR Text Key: 104250386
• Report Number: 3002808486-2018-00396
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002449760
• UDI-Public: (01)10827002449760(17)201219(10)E3666853
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2020
• Device Catalogue Number: ZTA-P-46-125-W1
• Device Lot Number: E3666853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/15/2018
• Device Age: 3 MO
• Date Manufacturer Received: 06/18/2018
• Date Device Manufactured: 12/19/2017
• 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): Life Threatening