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-38-197-W
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to complainant: this was off label use.The locking mechanism on the blue handle needed to be loosened using forceps.The bare metal stent did not deploy after being unsheathed.It did deploy after being resheathed and twisted.The procedure was a success and the patient is doing fine.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Summary of investigational findings: the investigation of this complaint was only based on the information provided in this complaint file.No product or imaging was received to support the output of this investigation.Based on the complaint history the most likely root cause of this event is most likely related to the steps in deployment sequence where it can be assumed that the sheath was not pulled back after unlocking the gray safety-lock knob.No evidence to suggest product was not manufactured according to specifications.Cook medical will continue to monitor for similar events.
Event or Problem Description
Description of event according to complainant: this was off label use.The locking mechanism on the blue handle needed to be loosened using forceps.The bare metal stent did not deploy after being unsheathed.It did deploy after being resheathed and twisted.The procedure was a success and the patient is doing fine.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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: 5836006
• Report Number: 3002808486-2016-00803
• Device Sequence Number: 18992183
• Product Code: MIH
• UDI-Device Identifier: 10827002353968
• UDI-Public: (01)10827002353968(17)190418(10)E3439319
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2016

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-38-197-W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2016
• Supplement Report FDA Received Date: 11/24/2016
• 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: Other
• Patient Age: 55 YR