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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blood Loss (2597); No Code Available (3191)
Date of Event	02/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
It was reported that a patient underwent an endovascular aortic aneurysm repair with placement of a zenith flex aaa endovascular graft bifurcated main body.Customer indicated that the inner lumen of the sheath valve dislodged while retracting the great dilator.An unspecified amount of blood leaked from the device.The sheath was removed and exchanged for another 20fr sheath to prevent further blood loss.There was 'some' unspecified anatomical tortuosity reported.No other procedural anomalies were reported.The procedure was successfully completed.There are no reported adverse patient outcomes related to this event.No further patient or procedure information was provided.The device was returned for evaluation.
Additional Manufacturer Narrative
A review of complaint history, device history record, documentation, instructions for use, manufacturing instructions, quality control, and visual inspection of returned partial device was completed during this investigation.The captor valve assembly was returned for investigation.Visual inspection confirmed that the un-notched iris valve and the valve control cap were not attached to the captor valve assembly, but were hanging on the gray positioner.One cause of iris valve detachment from the assembly is retraction of the gray positioner while the valve is in the closed position, due to the friction on the valve from the motion of the positioner.However, the complaint indicated that the valve was open during the retraction of the gray positioner.The three silicone-disc parts were intact and apart of the captor valve assembly.This suggests that the blood loss was due to blood collected between the discs and valve during the procedure and was released when the valve was removed.The ifu states that, "it is important to monitor blood loss from the hemostatic valve throughout the procedure, but is specifically relevant during and after manipulation of the gray positioner.After the gray positioner has been removed, if blood loss is excessive, consider placing an uninflated molding balloon or an introduction system dilator within the valve, restricting flow." also the ifu states during positioner retraction to "ensure the captor hemostatic valve on the main body introducer sheath is turned to the open position." review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the available information, the root cause is related to leakage at the hemostatic valve.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.

• Brand Name: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6387455
• Report Number: 1820334-2017-00332
• Device Sequence Number: 16327585
• Product Code: MIH
• UDI-Device Identifier: 10827002484242
• UDI-Public: (01)10827002484242(17)180803(10)7144531
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TFFB-30-111-ZT
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/07/2017
• Supplement Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 03/08/2017
• Supplement Report FDA Received Date: 08/23/2017
• 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