MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G32537
Health Effect - Clinical Codes	Death (1802); Unspecified Infection (1930); Paralysis (1997)
Date of Event	04/29/2014
Type of Reportable Event	Death
Event or Problem Description
The following information was discovered during a literature search where the article described the event (but did not list a manufacturer or device information) as the patient developed acute paralysis 3.5 hours post procedure.Multiple thrombi were identified in the territory of the graft (the aorta, left renal, bilateral common external iliac arteries and bilateral superficial femoral and profunda femoral arteries) at the time of exploratory laparotomy.This was treated with thrombectomies, patch angioplasties and angiojet of the graft.Histologic processing of the extracted aortic thrombi showed identical polymers to those seen in the gastrointestinal resection specimen.One day after the aortic repair the patient developed melena, ultimately requiring proctectomy due to the intraoperative impression of ischemia.Three days after the aortic repair the patient died of cardiac arrhythmia in the setting of renal and respiratory failure.A specific date of death has not been supplied.(an earlier description of the event described the time between the event and the patient death as longer in duration).On 5th april 2019, the manufacturer received a response to their enquiries which detailed the device codes and lot numbers.
Additional Manufacturer Narrative
The device was not returned for evaluation.Work order (b)(4) was reviewed and appears complete and correct.The device ifu states: "to activate the hydrophilic coating on the outside of the flexor introducer sheath, the surface must be wiped with 4x4 gauze pads soaked in saline solution.Always keep the sheath hydrated for optimal performance." 100% of sheath assemblies are qc inspected for any surface non-conformities.Based on the information provided, a definitive root cause could not be determined.
Event or Problem Description
The following information was discovered during a literature search where the article described the event (but did not list a manufacturer or device information) as: the patient developed acute paralysis 3.5 hours post procedure.Multiple thrombi were identified in the territory of the graft (the aorta, left renal, bilateral common external iliac arteries and bilateral superficial femoral and profunda femoral arteries) at the time of exploratory laparotomy.This was treated with thrombectomies, patch angioplasties and angiojet of the graft.Histologic processing of the extracted aortic thrombi showed identical polymers to those seen in the gastrointestinal resection specimen.One day after the aortic repair the patient developed melena, ultimately requiring proctectomy due to the intraoperative impression of ischemia.Three days after the aortic repair the patient died of cardiac arrhythmia in the setting of renal and respiratory failure.A specific date of death has not been supplied.(an earlier description of the event described the time between the event and the patient death as longer in duration.) on 5th april 2019 the manufacturer received a response to their enquiries which detailed the device codes and lot numbers.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane QLD 4 113; AS QLD 4113
• MDR Report Key: 8520994
• Report Number: 9680654-2019-00015
• Device Sequence Number: 1928615
• Product Code: MIH
• UDI-Device Identifier: 10827002325378
• UDI-Public: (01)10827002325378(17)170320(10)AC934190
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2019

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 Expiration Date: 03/20/2017
• Device Model Number: G32537
• Device Catalogue Number: ZFEN-P-2-28-109-R
• Device Lot Number: AC934190
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ZFEN-D-12-28-76-C LOT NO: AC934191.; ZFEN-D-12-28-76-C LOT NO: AC934191.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 77 YR