MAUDE Adverse Event Report: COOK, INC. ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER

Catalog Number ESC-32-12-80

Device Problem Rupture, cause unknown (1548)

Patient Problems Death (1802); Rupture (2208)

Event Date 08/19/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, an (b)(6) male pt who previously had aaa replacement with a y-graft (manufacturer unk) in 2011 underwent ruptured aaa repair urgently.L1 was 40mm and the access vessel, the left femoral was 9mm of the artificial vessel.At 15:00, the physician placed the zenith aaa endovascular graft aaa ancillary component converter at the suspected, ruptured site, the anastomotic part of the y-graft in the proximal side.At 15:30, the pt's blood pressure decreased to under 40 and his condition worsened suddenly.At 15:45, the physician confirmed that there was bleeding by dsa, but could not locate the exact bleeding site.Immediately the procedure was converted to an open surgery.Around 17:00, exact bleeding site still could not be confirmed by laparotomy.Around 17:30, the y-graft and the zenith aaa endovascular graft aaa ancillary component converter were replaced with a new one artificial vessel.Around 20:00, the pt taken to the icu after surgery.The pt is out of critical condition, but still in unpredictable condition.Add'l info about the death provided on 09/02/2014.The date of death is corrected to (b)(6) 2014.On (b)(6) 2014, the physician determined the bleeding from the aorta had not stopped, so another open surgery was performed.He treated the anastomotic part.He also confirmed the ischemia of the colon, but could not remove any necrotic part.On (b)(6) 2014, the pt had dic from massive hemorrhage due to aorta rupture.Then he deceased due to septicemia from bowel ischemia (necrosis) due to prolonged interruption of blood flow of the aorta.The autopsy found necrosis of the descending colon.The physician commented as below: i can't say there was no relation between this event and the converter graft because the bleeding started again after insertion of the device.However, after considering pt's condition (aorta rupture), and device which could be used at that point, it couldn't be helped.

Manufacturer Narrative

(b)(4).Event is still under investigation.

• Brand Name: ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4128855
• MDR Text Key: 15351710
• Report Number: 1820334-2014-00429
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2015
• Device Catalogue Number: ESC-32-12-80
• Device Lot Number: 4080887
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/19/2014
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 08/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 82 YR