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 Expiration Issue (1216)
Health Effect - Clinical Code	Death (1802)
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
The patient arrived to the emergency room with a ruptured abdominal aorta.It was decided that they were going to try and perform an endovascular procedure in order to save the patient's life.The patient coded while in the er and was immediately transported to the operating room.In the operating room.It was determined that the graft needed for the repair had an expired date, but they felt it was still the patients only option at the time so it was implanted.According to the initial reporter, the patient did not survive the procedure due to the massive amount of internal bleeding from the ruptured aorta.
Additional Manufacturer Narrative
Date of event requested but not provided.(b)(4).Event evaluation a review of the device history record and the instructions for use (ifu) was conducted during the investigation.The device was not returned to assist in the investigation.The batch record for lot 4774622 was reviewed.It was confirmed that the product was manufactured in february of 2014 with a two year shelf life expiring in february of 2016.There were no issues/non conformances generated during the manufacturing of this device.There is no evidence to suggest that the product was not manufactured to the correct specifications.It should be noted that prior to implanting cook's device the patient aneurysm had ruptured.Once an aneurysm ruptures, the chance for survival is greatly reduced.Although endovascular repair can sometimes be done for a leaking or bleeding aneurysm, as in this case, the internal bleeding caused by the rupture was too severe.Therefore, the adverse event related to this case was most likely related to the morbidity of the patient prior to the procedure rather than complications stemming from the use of the device.The root cause was linked to the procedure itself along with the patient's condition being related to the occurrence.
Event or Problem Description
The patient arrived to the emergency room with a ruptured abdominal aorta.It was decided that they were going to try and perform an endovascular procedure in order to save the patient¿s life.The patient coded while in the er and was immediately transported to the or.In the or it was determined that the graft needed for the repair had an expired date, but they felt it was still the patients only option at the time so it was implanted.According to the initial reporter, the patient did not survive the procedure due to the massive amount of internal bleeding from the ruptured aorta.

• 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: 5584649
• Report Number: 1820334-2016-00258
• Device Sequence Number: 942265
• Product Code: MIH
• UDI-Device Identifier: 10827002484228
• UDI-Public: (01)10827002484228(17)160201(10)4774622
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TFFB-30-82-ZT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 26 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2016
• Supplement Report FDA Received Date: 11/29/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death