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

Model Number	G35361
Medical Device Problem Codes	Failure to Unfold or Unwrap (1669); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Description of event according to initial reporter: the alpha was advanced into position, overlapping a previously implanted alpha thoracic graft, when deployed and trigger wires removed, the most proximal stent was not fully expanded, the appearance was as though it was being constrained.A coda balloon was then advanced over the lunderquist wire and inflated however burst upon inflation.A 26x40 atlas balloon was then inflated numerous times but the most proximal stent remained perpendicular to the others.After a sternotomy was performed and the endograft taken out, physician commented that it was not the delivery system or the endograft itself that caused the problem, it was a combination of the arterial anatomy (angle and lumen size) and the indwelling endograft that caused the stent strut to get trapped.Patient outcome: the patient did require additional procedures due to this occurrence.Sternotomy followed by removal of endograft.According to initial reporter, the patient did not experience any adverse effects do to this occurrence.

• 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: 9916616
• Report Number: 3005580113-2020-00342
• Device Sequence Number: 16318878
• Product Code: MIH
• UDI-Device Identifier: 10827002353616
• UDI-Public: (01)10827002353616(17)221024(10)E3912934
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2020
• Report Date (Section F): 04/02/2020

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: 10/24/2022
• Device Model Number: G35361
• Device Catalogue Number: ZTA-P-40-117-W
• Device Lot Number: E3912934
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/05/2020
• Event Location: Other
• Date Report to Manufacturer: 04/02/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2020
• 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
• Date Report Sent to FDA: 04/02/2020