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-30-109-W
Medical Device Problem Codes	Failure to Advance (2524); Delivery System Failure (2905)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Similar to device with 510(k) p140016.Investigation is still in progress.
Event or Problem Description
Description according to initial reporter: left side was accessed dilators passed, unable to pass 16 fr.Dilator.Right side was accessed dilators passed, unable to pass 16 fr.Dilator.Viabahn stent 9 mm was placed and ballooned with 9 mm x 4 cm balloon throughout stent.Dilators were passed again in sequential 14 fr., 16 fr., & 18 fr.Successfully.Attempted to pass device still would not advance.Reballooned and repassed dilators, attempted device again ridges noted in the sheath, device would not advance.Opened different device and it passed without incidence.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: based the event description, it was possible to conclude, that the physician had access problems when using the dilators and when attempting to introduce the product.This was reflected by the need of redilation and re-ballooning by the physician.These problems are most likely related to patient anatomy and unsuitable preoperative case planning by the physician.The transverse ridges on the distal sheath are most likely caused by manipulation of the product during attempt to introduce the product, as the ridges were not seen during unpacking the product, only after manipulation of the product.Cook medical will continue to monitor for similar events.
Event or Problem Description
Description according to initial reporter: left side was accessed dilators passed, unable to pass 16 fr.Dilator.Right side was accessed dilators passed, unable to pass 16 fr.Dilator.Viabahn stent 9 mm was placed and ballooned with 9 mm x 4 cm balloon throughout stent.Dilators were passed again in sequential 14 fr., 16 fr., & 18 fr.Successfully.Attempted to pass device still would not advance.Re-ballooned and repassed dilators, attempted device again ridges noted in the sheath, device would not advance.Opened different device and it passed without incidence.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: 5938420
• Report Number: 3002808486-2016-01038
• Device Sequence Number: 456578
• Product Code: MIH
• UDI-Device Identifier: 10827002353418
• UDI-Public: (01)10827002353418(17)190623(10)E3464158
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2016

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-30-109-W
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2016
• Supplement Report FDA Received Date: 11/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR