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

Catalog Number	ZTA-P-36-209-W
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: during deployment, there was a lot of difficulty retracting the sheath.Once the sheath got to the first part of the bare stent, there was extreme difficulty retracting the sheath any more.They heard a snap.They believe that the sheath's nitinol core broke.Because the sheath would not retract from that point on, there was fear to try to complete deployment any further.It was decided to remove the delivery system and replace with a new graft.They completed the procedure successfully with a shorter graft (36 x 161).The physician and rep suspect that the tight aortic arch made deployment difficult.Patient outcome: 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: this investigation was based on investigation of the returned product, and information provided.Investigation of the product showed elongation of the flexor sheath at the captor hemostatic valve, probably due to the attempt to withdraw the sheath.It was not possible to withdraw the sheath.The system was flushed and the elongated part of the sheath was cut off by transverse cuts, after which withdrawal and complete deployment was possible.No other irregularities were seen on the product.As per ifu certain anatomic elements may result in difficulty when attempting to withdraw the sheath, including severe angulation and tortuosity.As described in the event description, the patient had a tight aortic arch, possibly making the deployment difficult.Imaging of patient anatomy were requested but not provided.Imaging would be helpful in determine whether patient anatomy affected deployment in this case.Without imaging it is not possible to determine the exact root cause of this event.The work order for the complaint device appears to be complete and correct, with no evidence to suggest that the device was not manufactured according to specification.The complaint file can be reopened if further information is provided.Cook medical will continue to monitor for similar events.
Event or Problem Description
Description of event according to initial reporter: during deployment, there was a lot of difficulty retracting the sheath.Once the sheath got to the first part of the bare stent, there was extreme difficulty retracting the sheath any more.They heard a snap.They believe that the sheath's nitinol core broke.Because the sheath would not retract from that point on, there was fear to try to complete deployment any further.It was decided to remove the delivery system and replace with a new graft.They completed the procedure successfully with a shorter graft (36 x 161).The physician and rep suspect that the tight aortic arch made deployment difficult.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due 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; 4632 bjaeverskov; DA
• MDR Report Key: 5938700
• Report Number: 3002808486-2016-01041
• Device Sequence Number: 1604022
• Product Code: MIH
• UDI-Device Identifier: 10827002353562
• UDI-Public: (01)10827002353562(17)190425(10)E3441615
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2016

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-P-36-209-W
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2016
• Supplement Report FDA Received Date: 03/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR