MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD UNKNOWN; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number UNKNOWN

Device Problems Therapeutic or Diagnostic Output Failure (3023); Migration (4003)

Patient Problems No Code Available (3191); Insufficient Information (4580)

Event Type  Injury  

Event Description

19 patients required intervention with cook medical devices : (male: 17, mean age 79 ± 7 years) underwent repair for failed endovascular aneurysm repair (evar).

Event Description

19 patients required intervention with cook medical devices : (male: 17, mean age 79 ± 7 years) underwent repair for failed endovascular aneurysm repair (evar).

Manufacturer Narrative

The device was not returned for evaluation.As the device type and lot number could not be provided, a review of the device history record could not be performed.The instruction for use provided with cook endovascular grafts provides information related to avoiding potential adverse events during the implant procedure, and states "the long-term performance of endovascular grafts has not yet been established.All patients should be advised that endovascular treatment requires life long, regular follow-up to assess their health and performance of their endovascular graft".Due to the lack of information provided in this complaint, it is difficult to determine a definitive root cause to explain the difficulties experienced by the patient.

• Brand Name: UNKNOWN
• Type of Device: 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: 11051520
• MDR Text Key: 223721912
• Report Number: 9680654-2020-00050
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 02/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention