MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT CAPTIVIA - FF; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number VAMF3838C150TE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemothorax (1896)

Event Date 05/23/2016

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A valiant captivia stent graft was implanted in the patient at the junction of the patients previously implanted valiant captivia stent grafts, to treat a thoracic rupture and distal stent graft migration.It was reported that hemothorax drainage was carried out approximately five days later.The cause of the event is undetermined.No additional clinical sequelae were reported and the patient will be monitored.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information received reported that the valiant captivia stent graft was implanted to at the junction of the patient's previously implanted valiant captivia stent grafts to resolve the aneurysm rupture and not to resolve the false lumen patency.The patient was reported to have been discharged three days later.It was reported that the cause of the endoprostheses dislocation is related to the enlargement of the secondary total aorta, and to the parietal fragility and the mechanical stresses of the stents on the wall.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - FF
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 9189831
• MDR Text Key: 162515523
• Report Number: 9612164-2019-04348
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2020

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 Expiration Date: 05/13/2020
• Device Model Number: VAMF3838C150TE
• Device Catalogue Number: VAMF3838C150TE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/15/2019
• Supplement Dates Manufacturer Received: 11/13/2019; 02/19/2020
• Supplement Dates FDA Received: 11/13/2019; 03/18/2020
• Date Device Manufactured: 05/14/2018
• 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: 59 YR
• Patient Weight: 59