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

Model Number	VAMF3030C150TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant stent graft system was implanted in a patient for the endovascular treatment of a 70 mm thoracoabdominal aneurysm.Calcification was noted in the external iliacs.It was reported during the index procedure the first device 30x30x150 valcap was advanced through the iliacs without trouble and placed in the correct position.However, the second device, 34x34x150 valcap would not advance through the iliac so it was removed followed by angioplasty of the iliacs.A re-attempt to place the device was made; however unsuccessfully.The device was removed from the right femoral and an 18fr sheath was placed to plug the hole.The device was advanced into the left iliac without issue and deployed.When the device was removed from the left iliac the patient¿ blood pressure dropped.An angiogram showed an external iliac rupture on the left side.The rupture was repaired.Once the left side was repaired the sheath in the right side was removed however the patients pressure dropped again.Another angiogram revealed the right external iliac had also ruptured.Two endurant limbs (10x10x82 and 13x13x 82) were placed in the right external iliac.The iliac was still leaking following the placement of the limbs so the physician performed an open exposure and repaired the right side.Per the physician, the cause of the event was anatomy related due to calcified access.No additional clinical sequelae were reported, and the patient is fine.

• Brand Name: VALIANT CAPTIVIA - FF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7637018
• Report Number: 2953200-2018-00890
• Device Sequence Number: 1555409
• Product Code: MIH
• UDI-Device Identifier: 00643169346994
• UDI-Public: 00643169346994
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/09/2020
• Device Model Number: VAMF3030C150TU
• Device Catalogue Number: VAMF3030C150TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR