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

Model Number	VAMC4646C100TU
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pain (1994); Rupture (2208)
Date of Event	04/18/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A valiant captivia stent graft system was implanted in a patient for the endovascular treatment of a 9.2 cm in diameter thoracic aortic aneurysm.It was reported that the patient presented emergently with back pain.The ct showed that the distal valiant stent graft had migrated proximally away from the celiac artery with a distal type i endoleak and aneurysm rupture.The physician elected to snorkel the sma and right renal.Another manufacturer¿s stent were implanted into the sma and right renal and another valiant stent graft was implanted.The final angiogram show that the snorkels were patent and the migration and distal type i endoleak were resolved.Per the physician, the cause of the migration and distal type i endoleak is related to the patient¿s anatomy, expansion of the distal thoracic aorta.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - CW
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6563945
• Report Number: 2953200-2017-00774
• Device Sequence Number: 10796443
• Product Code: MIH
• UDI-Device Identifier: 00643169346642
• UDI-Public: 00643169346642
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/09/2017
• Device Model Number: VAMC4646C100TU
• Device Catalogue Number: VAMC4646C100TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2017
• Supplement Date Received by Manufacturer: 04/18/2017
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 10/03/2017
• 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: 85 YR