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

Model Number	VAMF3838C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2018
Type of Reportable Event	Malfunction
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 thoracic abdominal aortic aneurysm.It was reported that during the index procedure final angiogram showed a small type ia endoleak.The proximal end of the graft was ballooned with a reliant however it is unknown it the endoleak resolved as a further angiogram was not carried out due to renal issues with the patient.Per the physician the cause of the event was patient's diseased aorta.No additional clinical sequelae were reported and the patient is being monitored.
Additional Manufacturer Narrative
Additional information: it was confirmed the previously reported renal issues that prevented further angiograms being performed on the patient was a pre-existing medical condition.Film analysis summary: the cause of the reported small type ia endoleak observed during implant could not be determined from the pre-implant films returned.Images during implant were not available for review, and the reported endoleak could not be assessed.Post-implant ct¿s were also not provided.Review of a pre-implant ct/3d film report revealed that the patient had an unknown size taa located in the mid-descending thoracic; ~10 cm caudal from the lsa.Just past the mildly angulated arch, the thoracic diameter along a 20mm length of the essentially straight proximal seal ranged from 31 ¿ 34mm, with moderate calcification and slight thrombus observed.The moderately calcified distal seal zone ranged in diameter from 30 ¿ 32mm, and the thoracic measured 30mm in diameter just above the celiac artery.No imaging was returned showing the access vessel morphology.The cause of the endoleak may have been anatomy related.However, other than the mild calcification and thrombus observed along the proximal seal, analysis of the returned films did not reveal any other anatomical characteristics that may have contributed to the reported endoleak.Due to a patient¿s reported renal issues, final angiogram post-ballooning could not be performed to confirm if the endoleak was still present at the end of the implant procedure.Therefore, it is possible that the type ia endoleak may have resolved after normal stent graft ballooning had been performed.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: 8173691
• Report Number: 9612164-2018-03684
• Device Sequence Number: 11199335
• Product Code: MIH
• UDI-Device Identifier: 00643169346956
• UDI-Public: 00643169346956
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2019
• Device Model Number: VAMF3838C150TU
• Device Catalogue Number: VAMF3838C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR