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 Codes	Difficult or Delayed Positioning (1157); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
During placement of a main body graft in an abdominal aortic aneurysm, the suprarenal stent was closed in the top cap and it was impossible to open it advancing with inner cannula.After deploying the graft, the second trigger was removed and the graft was stabilized with a balloon.The suprarenal stent was opened by advancing with the inner cannula and grey positioner.The procedure was prolonged due to the occurrence.
Additional Manufacturer Narrative
Evaluation- a review of the following: complaint history, device history record, drawing, ifu, mi, qc, specifications, and visual inspection of the returned device was conducted.The device history record was reviewed and no non-conformances were noted.There is no evidence that the product was manufactured out of specification.This complaint is the only one associated to the complaint lot number due to this product only having one per lot.During the procedure, the physician was unable to easily deploy the suprarenal stent.It was said to be "impossible to open stent advancing with the inner cannula.Removed second trigger after deploying graft." they then inflated the reliant balloon to stabilize the graft and opened it through advancing the inner cannula and the gray positioner, following the ifu troubleshooting section instructions.The returned device showed that the pin vise was completely unscrewed, suggesting that the physician did not dock the top cap at the end of the procedure.It is possible that the physician did not loosen the pin vise prior to attempting to advance the top cap, which could have caused the difficulty with deployment; this has been seen in previous cases.Trying to remove the trigger wire at the wrong time could also lead to difficulties during deployment.Anatomy could have also caused a problem if the neck was out of ifu requirements.The physician performed the steps out of order (removing the second trigger wire was performed out of order), which could not have caused the problem seen here, but may caused future issues.Due to not having more information, the root cause is unknown.This issue could be due to surgical procedure, device malfunction, or patient anatomy.

• 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: 5956913
• Report Number: 1820334-2016-00974
• Device Sequence Number: 10890183
• Product Code: MIH
• UDI-Device Identifier: 10827002484129
• UDI-Public: (01)10827002484129(17)180222(10)6725178
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2017

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: N/A
• Device Catalogue Number: TFFB-26-82-ZT
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2016
• Supplement Report FDA Received Date: 05/30/2017
• 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