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

Model Number	VAMF4646C200TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Death (1802)
Date of Event	02/06/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Concomitant medical products: vamc4242c150tu, sn (b)(4), expiration date: 2018-11-09, udi # (b)(4); vamc4642c150tu, sn (b)(4), expiration date: 2018-11-16, udi # (b)(4).Film evaluation summary: the exact cause of the post-implant pulmonary embolism leading to patient death cannot be conclusively determined from the pre-implant 3d recon report provided.Films at implant were not provided.It is possible that the pulmonary embolism was related to the procedure to implant the valiant stent grafts.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 stent graft system was implanted in a patient for the endovascular treatment of a 7.2 cm in diameter thoracic aortic aneurysm.It was reported that post index procedure, the patient had a low platelet count and the spinal drain had not been removed.The patient was getting platelets.The patient was alert and oriented.Approximately, ten days later the patient felt like they had to belch.Twelve days later the patient collapsed and died.Per the physician they felt it was the result of a pulmonary embolism.The family refused to have an autopsy performed.Per the physician, the event was not related to the device but may have been related to the procedure or to the hospital stay.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: 6412014
• Report Number: 2953200-2017-00406
• Device Sequence Number: 13585513
• Product Code: MIH
• UDI-Device Identifier: 00643169346512
• UDI-Public: 00643169346512
• 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): 02/23/2017

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: 05/09/2018
• Device Model Number: VAMF4646C200TU
• Device Catalogue Number: VAMF4646C200TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Initial Date Received by Manufacturer: 02/23/2017
• Supplement Date Received by Manufacturer: 02/23/2017
• Initial Report FDA Received Date: 03/16/2017
• 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: 85 YR