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

Model Number	VAMF3838C200TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: vamc3838b100tu, sn (b)(4), expiration date: 2015-07-18, udi # (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 or Problem Description
A valiant captivia stent graft system was implanted in a patient for the endovascular treatment of an 8.6 cm thoracic aortic aneurysm.It was reported that a ct taken, revealed growth in the aneurysm sac without any evidence of an endoleak.The physician stated that the cause of the event could not be determined.The patient received an intervention where the physician implanted proximal and distal extensions with aptus endoanchors in order to improve the seal zones.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Evaluation summary: the exact cause of the aneurysm enlargement cannot be conclusively determined from the films provided.Films at implant and earlier post-implant films were not provided.The films provided showed that there is currently marginal proximal stent graft seal within the tortuous descending aorta.Contrast was seen outside of the proximal stent graft along the posterior side.However, the contrast did not appear to be feeding the aneurysm sac as there appears to be good seal near the second stent ring.The aorta surrounding the proximal stent graft appears to have dilated from disease progression, which likely led to the marginal proximal seal.Although no obvious endoleak was observed, it is possible that the thoracic aortic aneurysm was pressurized from the marginal proximal stent graft seal within the highly angulated section of the thoracic aorta, which resulted in the aneurysm enlargement.
Additional Manufacturer Narrative
Corrected information: sex, date of birth, no eval explain code.If information is provided in the future, a supplemental report will be issued.

• 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: 6450932
• Report Number: 2953200-2017-00503
• Device Sequence Number: 693779
• Product Code: MIH
• UDI-Device Identifier: 00613994797971
• UDI-Public: 00613994797971
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/18/2015
• Device Model Number: VAMF3838C200TU
• Device Catalogue Number: VAMF3838C200TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: Not provided; 04/04/2017
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 04/10/2017; 10/02/2017
• 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: 83 YR