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

Model Number	VAMF4242C200TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Pleural Effusion (2010); Vascular Dissection (3160)
Date of Event	02/18/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Film evaluation summary: films at implant and post-implant films that showed the type a dissection were not returned for review.The exact implant location of the valiant stent graft was unknown.The pre-implant 3d recon report showed that there appears to be some thickening of the aortic wall, starting from just below the lsa and extended to ~ 115 mm past the left subclavian artery.The wall thickening may have been periaortic intramural hematoma.However, the pre-implant ct's were not returned for review; a complete assessment of the anatomy cannot be performed, so the intramural hematoma cannot be confirmed.The exact cause of possible type a dissection in the ascending aorta, bilateral pleural effusions, diminished brain functions, and patient death cannot be conclusively determined from the pre-implant 3d recon report provided.However, it is possible that the events may have been related to the proximal extension of the periaortic intramural hematoma.
Event or Problem Description
A valiant stent graft system was implanted in a patient for the endovascular treatment of a 7 cm in diameter thoracic aneurysm.It was reported that four days post index procedure that the patient was up walking and suddenly collapsed and coded.The physician stated the patient had a cat scan that revealed no endoleak present however, there were bilateral pleural effusions.The physician also stated that it is possible that there was a small type a dissection of the ascending aorta.The patient was kept on life support.A brain scan was performed with diminished brain function; the family requested the patient be removed from life support.The patient expired.Per the physician, the cause of the event was due to proximal extension of the periaortic intramural hematoma.No additional clinical sequelae were reported.
Additional Manufacturer Narrative
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: 6441317
• Report Number: 2953200-2017-00466
• Device Sequence Number: 10842251
• Product Code: MIH
• UDI-Device Identifier: 00643169346536
• UDI-Public: 00643169346536
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2017

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: 11/10/2018
• Device Model Number: VAMF4242C200TU
• Device Catalogue Number: VAMF4242C200TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Initial Date Received by Manufacturer: 03/02/2017
• Supplement Date Received by Manufacturer: 03/02/2017
• Initial Report FDA Received Date: 03/28/2017
• Supplement Report FDA Received Date: 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: Death
• Patient Age: 78 YR