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

Model Number	G35333
Medical Device Problem Codes	Leak/Splash (1354); Occlusion Within Device (1423)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	09/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.(b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: "global product manager, was attending the (b)(6) meeting, during which, a physician, presented a case utilizing the zenith alpha device.The case was presenting the use of the zenith alpha device in an off label manner, treating an aortic coarctation.During the follow-up imaging, there looked to be a type 2 or 3 leak as well as some thrombus built-up in the graft.This event caused some concern about the thrombus as well as if the leak was a type 3 endoleak (tear in the graft).The graft utilized was a 24mm graft and was dilated with a 14mm non-compliant pta balloon, but nothing larger.It is unknown how the physician will be treating this, but the audience recommended continued follow-up.This complaint was entirely from the perspective of global product manager, whom was present for the meeting.Additional information recieved 18sep2017: "the device was used in an off-label manner by treat an aortic coarctation, which the device is not indicated.The type of endoleak has not been further determined/analyzed and treatment at this time is for a follow-up ct at 6 months."physician was evaluating what the next steps would be to manage the type ii/iii, since there was a discussion on what type of endoleaks it was.There was a collateral vessel that was feeding the focal aneurysm beyond the aortic coarctation".Patient outcome: patient is doing fine currently with no symptoms".
Additional Manufacturer Narrative
Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: this complaint concerns a patient treated with an alpha graft for aortic coarctation.The zenith alpha thoracic endovascular graft is indicated for the endovascular treatment of patients with aneurysms and ulcers of the descending thoracic aorta.Thus, the alpha graft was used outside of ifu indications, which was also stated in the event description.As per ifu endoleak and arterial thrombosis are known potential adverse events.Additional surveillance and possible treatment is recommended for these events.No evidence to suggest that the device was not manufactured according to specification.Cook medical will continue to monitor for similar events.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 6908262
• Report Number: 3002808486-2017-01901
• Device Sequence Number: 10940695
• Product Code: MIH
• UDI-Device Identifier: 10827002353333
• UDI-Public: (01)10827002353333(17)190907(10)E3490760
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P140016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: G35333
• Device Catalogue Number: ZTA-P-24-105-W
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/08/2017
• Device Age: 12 MO
• Initial Date Received by Manufacturer: 09/18/2017
• Supplement Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 01/12/2018
• 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: Life Threatening
• Patient Age: 34 YR