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

Model Number	VAMC4040C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a 75mm diameter thoracic aortic aneurysm.The distal neck is 20mm in length and it is 36mm, 29mm, 36mm in diameter from proximal to distal, irregular shaped.It was reported that after review of the follow-up ct it was determined that the patient most likely has a distal type i endoleak.The patient has not and will not receive treatment.The physician stated that the cause of the event was anatomy related, short distal seal zone.No clinical sequelae were reported and the patient will be monitored by their physician.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Failure to follow instructions stent graft oversizing internal film review: review of pre-implant angio and ct/3d film report revealed that the patient had a 73mm max diameter taa which was located within the mid-level of the descending thoracic.Just caudal to the lsa, the thoracic diameter measured 29 x 32mm, 50mm caudal was 37 x 39mm, 100mm caudal was 33 x 36mm, and 150mm caudal to the lsa the thoracic diameter was 40 x 43mm.Just proximal to the celiac, the thoracic diameter measured 37 x 39mm, 13mm proximal narrowed down to 27mm, and 20mm proximal to the celiac narrowed to 23 x 29mm in diameter.Slight calcification was seen along the length of the descending thoracic, which was essentially straight.Review of ct¿s from 3 weeks post-implant revealed that 2 valiant stent grafts had been implanted in the patient¿s descending thoracic; beginning just below the arch.The proximal stent graft od measured ~34mm.Near the mid-length of the devices, the 2 stent grafts were overlapping ~4cm; the overlapping od measured ~35mm.Near the mid-length of the distal main device, the stent graft od measured ~40mm and the taa max diameter measured ~73mm.A short distal seal length (~20mm) was seen; a single distal stent from the distal main was seen positioned within the narrowed distal neck.The stent graft was considerably compressed and was likely infolded.Approximately 5mm from the celiac artery, the distal od measured ~24mm and there was contrast seen within the taa coming from a likely distal type i endoleak.The stent graft was patent.The patient had a previously placed aorta-bi-femoral surgical graft.Review of ct¿s from 3 months post-implant revealed there was little change in stent graft configuration compared to the previous (3-week) films.The proximal stent graft od measured ~35mm.Near the mid-length of the devices, the 2 stent grafts were overlapping ~4cm; the overlapping od measured ~37mm.Near the mid-length of the distal main device the stent graft od measured ~40mm and the taa max diameter measured ~73mm.A short distal seal length (~20mm) was again seen; a single distal stent from the distal main was seen positioned within the narrowed distal neck.The stent graft was considerably compressed and had likely infolded.Approximately 5mm above the celiac artery the distal stent graft od measured ~25mm and there was contrast seen within the taa coming from a likely distal type i endoleak.The stent graft was patent.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: 6659144
• Report Number: 2953200-2017-01021
• Device Sequence Number: 1157274
• Product Code: MIH
• UDI-Device Identifier: 00643169346833
• UDI-Public: 00643169346833
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 07/10/2017

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: 11/17/2018
• Device Model Number: VAMC4040C150TU
• Device Catalogue Number: VAMC4040C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: 07/10/2017; 07/10/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 08/03/2017; 10/04/2017
• 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