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

Model Number	G35401
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2017
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: graft was deployed and the user removed the 1st trigger wire (green handle).Upon deploying the bare stent, the user attempted to remove gray thumb screw, having to use forceps to loosen.At this time the user still could not use the black slide bar.To remedy this the dm instructed the physician to break back off green handle, which loosened the slide bar.The procedure was able to be completed and was overall successful.Patient outcome: the patient did not require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: the reported information in the description of event states difficulty deploying the stent graft which resulting in performing the described troubleshooting method in ifu.Based on the further received information, the difficulty concerns the release of the stent graft from the bottom cap.The evaluation of the returned device revealed marks inside the bottom cap.According to the complaint history, these marks likely appear when the distal bare stent is released in an angulated distal thoracic aorta that exceeded the recommended in ifu (localized angulation > 45 degrees).This can not be verified as the imaging was not provided.Therefore this pr falls under the scope of a previously initiated internal action where further investigation, regarding difficulties in releasing the bare stent from the bottom cap, is conducted.No evidence to sugest that the device was not manufatured according to specifications cook medical will continue to monitor for similar events.

• 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; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 6371141
• Report Number: 3002808486-2017-00687
• Device Sequence Number: 395228
• Product Code: MIH
• UDI-Device Identifier: 10827002354019
• UDI-Public: (01)10827002354019(17)190108(10)E3402237
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P140016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2017

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 Model Number: G35401
• Device Catalogue Number: ZTA-D-44-157-W
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/17/2017
• Device Age: 13 MO
• Initial Date Received by Manufacturer: 02/17/2017
• Supplement Date Received by Manufacturer: 02/17/2017
• Initial Report FDA Received Date: 03/02/2017
• Supplement Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR