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

Model Number VAMF3636C150TE

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

Patient Problems Death (1802); Heart Failure (2206); Multiple Organ Failure (3261)

Event Date 01/24/2019

Event Type  Death  

Manufacturer Narrative

Other relevant device(s) are: valiant stent graft, catalog number: unknown, serial number: unknown, use by date: unknown and upn# unknown, valiant stent graft, catalog number: unknown, serial number: unknown, use by date: unknown and upn# unknown.Journal article details; alternative debranching in patients with thoracoabdominal aortic aneurysm after open and endovascular aortic aneurysm repair patrick nierlich, florian k.Enzmann, julio ellacuriaga-san martin, klaus linni, and thomas holzenbein annals of vascular surgery.Doi: https://doi.Org/10.1016/j.Avsg.2018.10.020.If information is provided in the future, a supplemental report will be issued.

Event Description

A valiant stent graft system was implanted in a patient for the endovascular repair of a greater than 110 mm ruptured visceral aortic patch aneurysm.It was reported that the patient had previously been treated with open surgery for an elective taaa type iii repair and presented in a very poor general condition.After stabilization in the icu, debranching and taa repair was carried out.Three valiant stent grafts were required to cover the whole aneurysmal area.It was reported that technical success was achieved with no paraplegia or other symptoms.However, the patient died two days after the procedure due to cardiac failure.

Manufacturer Narrative

Other relevant device(s) are: valiant captivia, catalog number: vamf3232c150te , serial number: (b)(4), use by date: 2019-07-17, (b)(4).Valiant captivia, catalog number: vamf3838c100te , serial number: (b)(4), use by date: 2019-07-11.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was confirmed that the death of the patient did not relate to use of the medtronic device.The patient expired due to multiorgan failure.

• 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: 8722023
• MDR Text Key: 148762097
• Report Number: 9612164-2019-02475
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Report Date: 08/27/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2019
• Device Model Number: VAMF3636C150TE
• Device Catalogue Number: VAMF3636C150TE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 06/21/2019
• Supplement Dates Manufacturer Received: 08/02/2019
• Supplement Dates FDA Received: 08/27/2019
• Date Device Manufactured: 07/18/2017
• 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
• Patient Weight: 82