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

Model Number	VAMC3228C150TU
Medical Device Problem Codes	Occlusion Within Device (1423); Folded (2630)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	01/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation, conclusion: failure to follow instructions (prior to the delivery of the third valiant stent graft, the guidewire was lost and then repositioned) film evaluation summary: the cause of the stent graft malformation seen after implanting the 3rd device, bridging across the 2 initially implanted devices, could not be determined from the films provided.This may be anatomy related.Ct's prior to implant were not available for return, and a complete assessment of the patient's anatomy could not be performed.It currently appears most likely that the 3rd implanted device was implanted outside the lumen of the previously implanted proximal main device #1, resulting in the incomplete expansion of the 3rd device, as well as infolding <(>&<)> malformation of the proximal main leading to stent graft occlusion.However, the exact cause could not be determined.This may have occurred due to a user issue; prior to implanting the 3rd device, the guidewire may not have been placed into the lumen of the proximal main device.
Event or Problem Description
A valiant stent graft system was implanted in a patient for the endovascular treatment of a 5 cm in diameter ulcer in the descending thoracic aorta.The thoracic aorta was non-tortuous.Two valiant stent grafts were deployed without issue.Prior to the delivery of the third valiant stent graft, the guidewire positioning was lost and then repositioned.It was reported that after the third distal valiant stent graft was deployed the top 1/3rd portion on one side of the stent graft appeared to be mal-deformed/infolded/crushed and not fully opposed against the other stent graft or vessel wall.After stent graft deployment, there was a pressure gradient between the thoracic area and the femoral artery area was more than 100 mm of mercury due to stenosis/thrombosis formation.The physician elected to perform an axillo-bi-femoral bypass.The blood flow was restored.The physician stated the cause of the event is related to the stent graft.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: 6317868
• Report Number: 2953200-2017-00175
• Device Sequence Number: 822775
• Product Code: MIH
• UDI-Device Identifier: 00643169346888
• UDI-Public: 00643169346888
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/23/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2018
• Device Model Number: VAMC3228C150TU
• Device Catalogue Number: VAMC3228C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Initial Date Received by Manufacturer: 01/23/2017
• Supplement Date Received by Manufacturer: 01/23/2017
• Initial Report FDA Received Date: 02/09/2017
• Supplement Report FDA Received Date: 09/29/2017
• 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: 62 YR