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

Catalog Number UNKNOWN

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog #: is unknown but referred to as cook alpha thoracic.Pma/510k: similar to device under pma/510(k) p140016.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: two years ago: a 78-year-old female patient received avr and tar with et for a widespread thoracic aortic aneurysm from ascending to descending thoracic aorta and aortic valve insufficiency.Two months after: tevar was performed using zenith devices.(34mm-161mm and 42mm-121mm).Later: open surgery was performed because of growth of the taa and vessel replacement with leaving only a stent graft that was placed in the proximal side was performed.About spinal perfusion, an extrathoracic network from the left subscapular artery to the intercostal artery (adamkiewicz artery) was found in the broad back muscle.Therefore, the chest was opened by excision of the costal arch on the anterior side and the left sixth intercostal space to preserve the broad back muscle.No paraplegia was confirmed after the surgery.Patient outcome: after the open surgery: no complications were confirmed except chylothorax, so the patient discharged from the hospital.

Manufacturer Narrative

Manufacturer ref# (b)(4).Additional information stated "the growth of taa was not due to cook¿s stent graft.This whole case was not due to cook¿s devices.It¿s not cook devices defect" therefore the event for this pr# is no longer reportable.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information received 07jul2022: the growth of taa was not due to cook¿s stent graft.This whole case was not due to cook¿s devices.It¿s not cook devices defect.

• 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
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 14785721
• MDR Text Key: 294565803
• Report Number: 3002808486-2022-00857
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

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
• Initial Date Manufacturer Received: 05/27/2022
• Initial Date FDA Received: 06/23/2022
• Supplement Dates Manufacturer Received: 07/07/2022
• Supplement Dates FDA Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female