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-42-204-W
Medical Device Problem Codes	Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to the initial reporter: during the tevar procedure, the physician attempted to land the zenith alpha thoracic endovascular graft at the left common carotid artery.As the device started to deploy it jumped back 4.5 cm ((b)(4)).The rest of the device deployed in the normal manor and released from the delivery system with no problems.Due to the 4.5 cm gap between the intended landing zone and the actual landing zone, a zta-p-46-125-w graft was successfully placed landing with the proximal graft edge at the ostium of the left common carotid artery.At this time a zta-d-42-204-w device was utilized and went through the deployment device sequence in the proper order.However, the distal bare stent appeared to be stuck in the bottom cap of the delivery system.The handle was dismantled and the physician pulled off all the trigger wires.The physician pulled the grey positioner down to the bottom of the device touching the bottom of the stent graft but the reverse tapered dilator tip of the stent graft bare metal stent and could not be removed.It was then noted that the bare stent must have crossed on itself at the stent apices ((b)(4)).At this point a wire was advanced from the contralateral common iliac artery and placed directly through one of the bare distal stents.A 6mm x 2cm boston mustang balloon was inflated in the stent and pushed up in a cephalad direction (towards the head) which released the stent, landing the graft in the targeted site".Patient outcome: the patient did require additional procedures due to this occurence: ballooning of the bare stent.
Additional Manufacturer Narrative
(b)(4).Summary of investigational findings: product examination showed a small amount of fraying at the sheath tip.The length of the parts that can be responsible for the reported event was measured and nothing indicates that the device was not manufactured according to specification.All the stent apices were gathered together but not crisscrossed.Entrapment of all the apices without sliding would have produced some visible apex crisscrossing.Consequently, a completely released bare stent entrapped on it self could not produce this appearance without same additional constraint provided by more than one of the bare stent wires sliding along its anchor suture.The most likely situation was persistent entrapment in the radiolucent portion of the distal positioner.Rather than advancing the delivery sheath as prescribed in the troubleshooting sequence in the ifu, all trigger wires were removed instead.Only friction provided by contact with the proximal component was still present to anchor the graft.Consequently, the operator could not pull down hard on the positioner because the graft was essentially free floating.The troubleshooting sequence of bare stent deployment difficulty was not followed.Consequently a balloon was required to free the stent.Balloon angioplasty was an effective, although potentially more problematic strategy, to free the stent as the balloon could have become entrapped in the stent barbs.The bare stent did not completely deploy.This is a known possibility with a prescribed troubleshooting sequence.Cook medical will continue to monitor for similar events.
Event or Problem Description
Description of event according to the initial reporter: during the tevar procedure, the physician attempted to land the zenith alpha thoracic endovascular graft at the left common carotid artery.As the device started to deploy it jumped back 4.5 cm ((b)(4)).The rest of the device deployed in the normal manor and released from the delivery system with no problems.Due to the 4.5 cm gap between the intended landing zone and the actual landing zone, a zta-p-46-125-w graft was successfully placed landing with the proximal graft edge at the ostium of the left common carotid artery.At this time a zta-d-42-204-w device was utilized and went through the deployment device sequence in the proper order.However, the distal bare stent appeared to be stuck in the bottom cap of the delivery system.The handle was dismantled and the physician pulled off all the trigger wires.The physician pulled the grey positioner down to the bottom of the device touching the bottom of the stent graft but the reverse tapered dilator tip of the stent graft bare metal stent and could not be removed.It was then noted that the bare stent must have crossed on itself at the stent apices ((b)(4)).At this point a wire was advanced from the contralateral common iliac artery and placed directly through one of the bare distal stents.A 6 mm x 2 cm boston mustang balloon was inflated in the stent and pushed up in a cephalad direction (towards the head) which released the stent, landing the graft in the targeted site".Patient outcome: the patient did require additional procedures due to this occurence: ballooning of the bare stent.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• MDR Report Key: 6042809
• Report Number: 3002808486-2016-01259
• Device Sequence Number: 16253790
• Product Code: MIH
• UDI-Device Identifier: 10827002354002
• UDI-Public: (01)10827002354002(17)190712(10)E3469775
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2016

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
• Operator of Device: Health Professional
• Device Catalogue Number: ZTA-D-42-204-W
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/20/2016
• Supplement Report FDA Received Date: 03/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention