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	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
Ipsilateral limb trigger wire could not be removed.The blue release knob was unable to be pulled backwards to release the wire.The blue knob appeared to be glued to the more posterior grey part of the pusher.The blue knob was removed with clamps to reach the wire and release the graft.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
This event is currently under investigation.
Event or Problem Description
No additional information was received.
Additional Manufacturer Narrative
Investigation: the zenith flex aaa endovascular graft returned for evaluation.Visual inspection of the device noted, the ipsilateral trigger wire release mechanism shows evidence of a plier-like tool to aid in removal.Evidence of glue was seen on the inside of the ipsilateral trigger wire release mechanism.The trigger wire knob was returned and showed no damages, it screws into the trigger wire release mechanism easily.The grip was returned removed from the system.Glue was evident on the trigger shaft, flowing approximately 1.5 cm in length from the trigger cap; glue width was approximately 6 mm.This suggests that the glue was applied to the threads of the trigger collar, as stated in associated manufacturing documents, but leaked downwards onto the trigger shaft.Either the trigger shaft was not wiped down as specified in associated manufacturing documents or not all of the glue was removed in that process.Most likely the trigger grips were placed onto the trigger shaft while the adhesive was still wet, causing the trigger grip closest to the trigger collar to be glued onto the trigger shaft.This would cause the difficulty with removing the trigger grip and would lead to the presence of dried glue on the returned device.According to the information in the complaint report and the device evaluation, the root cause is due to the issue occurring during manufacturing.A review of the complaint history, device history record, ifu, quality control and visual inspection of the returned device was conducted.No events related to the reported issue were found during a review of related manufacturing or quality records.Review of the associated device history record did not identify non-conformances that may be related to this reported incident.Appropriate actions have been taken to address this non-conformance.We will continue to monitor 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: 6020022
• Report Number: 1820334-2016-01081
• Device Sequence Number: 10988554
• Product Code: MIH
• UDI-Device Identifier: 10827002484228
• UDI-Public: (01)10827002484228(17)180525(10)6979963
• Combination Product (Y/N): N
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2016

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 Model Number: N/A
• Device Catalogue Number: TFFB-30-82-ZT
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/13/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/12/2016
• Supplement Report FDA Received Date: 02/01/2017; 03/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 75