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

Model Number	G35355
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).(b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: alpha device used for a thoracic aneurysm.Looks like a type 3 endoleak at steepest curve of the arch.Reintervention on (b)(6) 2019 to implant another alpha (zta-p-38-167-w) to seal off leak.The patient no longer has a leak.First implant was tuesday, (b)(6) 2019.The doctor scanned the patient (b)(6) 2019 and saw an endoleak.He wasn¿t sure if it was a type 1a or type 3.He lined the graft with a new alpha on (b)(6) 2019.The patient does not have a leak any more.The graft landed in zone 2, just distal to the carotid artery.Patient outcome: the patient did require additional procedures due to this occurrence: an additional implant of an alpha device was scheduled for (b)(6) 2019 to seal off endoleak.A zta-p-38-167-w was implanted on (b)(6) 2019.Doctor is happy with final result.Has the complainant reported that the product caused or contributed to the adverse effects: no.
Additional Manufacturer Narrative
Manufacturers ref# pr287522 summary of investigational findings: a male patient with thoracic aortic aneurism had a tevar procedure performed (b)(6) 2019, where zta-p-36-161-w (complaint device) was implanted in zone 2.The physician scanned the patient (b)(6) 2019 and found an endoleak, not sure if it was a type 1a or a type 3 endoleak.Therefore the patient underwent another tevar procedure where an additional stentgraft (zta-p-38-167-w) was implanted, lined with the existing stentgraft, and sealing the leak.The endoleak was no longer there.No adverse effects to the patient have been reported.½review of the device history record gave no indication of the device being produced outside of specifications.The ifu sent with the device states: ¿patients experiencing leaks or reduced blood flow through the graft may be required to undergo secondary endovascular interventions or surgical procedures¿ and according to the ifu, endoleak is a known adverse event.A likely cause for this event could not be established.Cook will reopen the investigation if further imaging or information is received.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 9556580
• Report Number: 3002808486-2020-00002
• Device Sequence Number: 11333335
• Product Code: MIH
• UDI-Device Identifier: 10827002353555
• UDI-Public: (01)10827002353555(17)221112(10)E3919966
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P140016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/12/2022
• Device Model Number: G35355
• Device Catalogue Number: ZTA-P-36-161-W
• Device Lot Number: E3919966
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 06/10/2020
• 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