MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number UNKNOWN

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Infarction, Cerebral (1771); Death (1802); Seizures (2063)

Event Type  Death  

Manufacturer Narrative

This event was reported by the manufacturer under mdr # 3002808486-2019-01779.

Event Description

The patient was treated for a thoracoabdominal aneurysm.The patient underwent a two-stage procedure.She first had a left carotid-subclavian transposition, which she tolerated well.Three months later, she had her aneurysm treated.A right ilioceliac bypass was done.A 10-mm pete graft was sewn end to side to the right common iliac artery as a conduit.Cook zenith alpha (zta-p-32-155) was deployed in zone 2, covering the origin of the left subclavian artery.Two custom stent grafts were then deployed with perfusion branches in the thoracic aorta and sma branch graft in the abdominal aorta.An iliac branch extension was inserted into the right common iliac artery (zsle 13-56).The patient immediately developed seizure postoperatively and deteriorated on pod 2 when her neurologic responses did not recover.Acute infarction, as well as microbleeds but no occlusion of middle cerebral artery.Autopsy examination confirmed hydrophilic polymer micro-emboli scattered through out the brain.The stent graft remained in the patient as intended.The patient had seizures immediately after surgery, acute infarction and microbleeds in brain and kidney infarction,and subsequently died.Autopsy revealed hydrophilic polymer microemboli in brain, kidney, arotic adventitia and liver.The zenith alpha thoracic has a hydrophilic coating on the introduction system, and thus could be contributing to the adverse effects.Patient deceased.

• Brand Name: UNKNOWN
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 9271866
• MDR Text Key: 164841057
• Report Number: 3005580113-2019-00713
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/04/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/04/2019
• Distributor Facility Aware Date: 10/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/04/2019
• 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
• Patient Age: 75 YR