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

Model Number VAMF3434C150TE

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

Patient Problems Death (1802); Swelling (2091)

Event Date 08/01/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A valiant captivia stent graft was implanted in a patient for the endovascular treatment of an orthopedic event.It was reported that the patient had spinal surgery 1 day prior to tevar.Pins and a plate were inserted to freeze upper thoracic vertebrae following the removal of a diseased vertebra.The pin was inserted through and through the vertebrae and was noted on ct to be pressing against the upper thoracic descending aorta with some changes noted to the aortic wall so the stent graft was implanted before the pin was removed.The pin was removed following the insertion of the stent graft.It was removed with the patient prone and when the patient was rolled over, they were 'brain dead' and expired.Cerebral odema was noted on ct.The stent graft was noted on ct as having zero migration or endoleaks and no dissections were seen.Per the physician the cause of the event cannot be determined.No additional clinical sequelae were reported.

• Brand Name: VALIANT CAPTIVIA ENDOVASCULAR STENT GRAFT
• 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: paola garnica ; 3576 unocal place; santa rosa, CA 95403 ; 7075661361
• MDR Report Key: 6837306
• MDR Text Key: 84306616
• Report Number: 2953200-2017-01371
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 08/08/2017

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: 11/22/2017
• Device Model Number: VAMF3434C150TE
• Device Catalogue Number: VAMF3434C150TE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2017
• Initial Date FDA Received: 09/01/2017
• Date Device Manufactured: 11/23/2015
• 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: 66 YR