MAUDE Adverse Event Report: WILLIAM COOK EUROPE CMD CODE ONLY THE DEVICE IS MADE UP OF THE BELOW ITEMS; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number THORACIC-LP-CMD-DEVICE

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2024

Event Type  Injury  

Event Description

Description of event according to initial reporter: "the only incorrect labeling was the last letter in the subject initials (incorrect gb/ correct gp).It was found only on the box and actual device.¿ the cmd tevar box for uab-389-gp had the wrong initial on it.The box was labeled ¿uab-389-gb.¿ all other documentation had the correct initials.1st stage tevar procedure was this morning (19mar2024) at 8am.

Manufacturer Narrative

Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.G07002 - appropriate term/code not available for label.Investigation is still in progress.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.

Manufacturer Narrative

Manufacturer ref# (b)(4).Investigation is still in progress.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 29mar2024: the device was still used for the tevar procedure, 1st stage tevar procedure was this morning ((b)(6) 2024) at 8am.Patient did well from his procedure and there were no adverse events associated with the mislabeled device.

Manufacturer Narrative

Manufacturers ref# (b)(4).After investigation the event for this pr# is no longer reportable.Summary of investigational findings: the thoracic-lp-cmd-device box for (b)(6) had the wrong initial on it.The box was labeled ¿(b)(6).¿ all other documentation had the correct initials.The device was still used in the 1st stage tevar (thoracic endovascular aortic repair) procedure.Patient did well from his procedure and there were no adverse events associated with the mislabeled device.One photo demonstrating the incorrect labeling on the box was provided.No device or box was returned for the investigation.An internal action has been initiated to address this issue and to investigate the cause of the event.This action is still ongoing.Cook medical will continue to monitor for similar events.This report is required by the fda under 21cfr 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

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: CMD CODE ONLY THE DEVICE IS MADE UP OF THE BELOW ITEMS
• 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; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: alex rahbek ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 18977815
• MDR Text Key: 338762848
• Report Number: 3002808486-2024-00057
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: THORACIC-LP-CMD-DEVICE
• Device Lot Number: E4509643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 03/27/2024; Not provided
• Supplement Dates FDA Received: 04/03/2024; 05/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2024
• 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