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 to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2016
Additional Manufacturer Narrative
(b)(4).Weight: unknown as information was not provided.Investigation is still in progress.
Event or Problem Description
Description of event according to complainant: during step 2 the device would not retract to release the trigger wires.The handle had to be taken apart to manually remove the trigger wires.Step 2 still could not be retracted.The physician then attempted to move the device around until the bare metal stent sprung open and then the sheath got caught on the bear metal fixation.The physician was able to pull back the sheath and remove the delivery system.At this point, the graft was not where the physician wanted it to be.The physician had to add another piece because the first one was not in position due to getting the device deployed.By adding the second piece the graft was able to be deployed.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: the investigation of the returned device identified damage on the tip of the flexor sheath.In addition, the length of the parts that can be responsible for the reported event was measured and nothing indicates that the device was not manufactured according to specification.Further investigation on the reported releasing difficulty and the confirmed damage on the flexor sheath revealed the most likely root cause to be 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.Skipping this step can likely result in unsheathing the distal end of the bare stent as the sheath covers part of the bottom cap.No evidence to suggest that the device was not manufactured according to specifications cook medical will continue to monitor for similar events.
Event or Problem Description
Description of event according to initial reporter: during step 2 the device would not retract to release the trigger wires.The handle had to be taken apart to manually remove the trigger wires.Step 2 still could not be retracted.The physician then attempted to move the device around until the bare metal stent sprung open and then the sheath got caught on the bear metal fixation.The physician was able to pull back the sheath and remove the delivery system.At this point, the graft was not where the physician wanted it to be.The physician had to add another piece because the first one was not in position due to getting the device deployed.By adding the second piece the graft was able to be deployed.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 DISTAL COMPONENTS
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• MDR Report Key: 5590224
• Report Number: 3002808486-2016-00236
• Device Sequence Number: 10961557
• Product Code: MIH
• UDI-Device Identifier: 10827002353968
• UDI-Public: (01)10827002353968(17)181110(10)E3385027
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2016

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ZTA-D-38-197-W
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2016
• 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: Required Intervention
• Patient Age: 78 DA