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

Model Number	VAMF4040C200TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Loss of distal seal with apparent distal endoleak was observed at the level of the distal stent graft margin of the valiant captivia devices already implanted in the patient prior to the (b)(6) 2022 procedure.It is most likely that aneurysm morphology changes due to disease progression with aneurysm morphology changes over the 6 years of implantation of the devices was a factor in the occurrence of the observed loss of seal leading to a distal endoleak.Analysis of the returned films did not reveal any stent graft integrity issues.Concomitant medical products: other relevant device(s) are: product id: v amc4040c200tu, serial/lot #: (b)(4), ubd: 10-may-2017, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant captivia was intended to be implanted during the endovascular treatment of a 67mm thoracic aortic aneurysm.It was reported that during the index procedure, the external iliac artery was torn upon insertion of the device.It was noted that the patient's blood pressure dropped until the pelvis was opened and the bleeding was controlled.The damaged vessel was surgically repaired.Per the physician, the cause of the event was anatomy related to a small external iliac artery.No additional sequelae were reported and the patient is fine.It was reported that the stent graft vamc4238c150tu/sn (b)(4) was not implanted in the patient.Another stent graft was opened and deployed.There were no issues with any other grafts used that day.

• Brand Name: VALIANT CAPTIVIA - FF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15868028
• Report Number: 9612164-2022-04440
• Device Sequence Number: 17457483
• Product Code: MIH
• UDI-Device Identifier: 00643169346543
• UDI-Public: 00643169346543
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/28/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: VAMF4040C200TU
• Device Catalogue Number: VAMF4040C200TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female