MAUDE Adverse Event Report: COOK INC ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	N/A
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that a problem was noticed with a zenith aaa endovascular graft aaa ancillary component main body extension.Prior to patient contact for a planned endovascular aneurysm repair procedure (evar) the surgeon noticed that there was a barb sticking through.Clarification has been requested but not yet received.The sheath wasn't smooth and they didn't wish to use this on a patient, so they used the spare device.The problem was discovered prior to patient contact.
Additional Manufacturer Narrative
Investigation/evaluation: visual inspection and dimensional verification was performed on the returned device.A review of complaint history, the device history record, instructions for use (ifu), and quality control data was also conducted.The actual complaint device was returned for analysis.This product was received in an un-deployed configuration, with the stent graft still sheathed.Blood was present on the delivery system.The sheath had been moved; as a gap existed between the sheath and the delivery system tip.There was an apex from the proximal sealing stent protruding from the proximal end of the sheath, along with a long scratch (2cm) at the same level of the protrusion.Based upon the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record showed there were no non-conformances related to the reported failure mode noted.A review of complaint history revealed there have been no other complaints received associated with the complaint product/lot 6556460.Each zenith device is shipped with instructions for use (ifu), listing the indications for use, contraindications, warnings and precautions, and the correct deployment procedure.Per the ifu, inspect the device and packaging to verify that no damage has occurred as a result of shipping.Do not use this device if damage has occurred or if the sterilization barrier has been damaged or broken.If damage has occurred, do not use the product and return to cook.Serrated markings were observed on the sheath tip consistent with scraping against a sharp object.These damages could be caused during manufacturing, shipping, device preparation or from tracking.Given the information available in the complaint and the pattern of damage, the root cause is likely related to handling of the packaged product.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.Appropriate personnel have been notified of this event.

• Brand Name: ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6693445
• Report Number: 1820334-2017-01600
• Device Sequence Number: 10955405
• Product Code: MIH
• UDI-Device Identifier: 10827002321844
• UDI-Public: (01)10827002321844(17)180129(10)6556460
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2018

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: N/A
• Device Catalogue Number: ESBE-32-39
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/16/2017
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1