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

Model Number	VAMF3838C200TU
Medical Device Problem Code	Difficult To Position (1467)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Myocardial Infarction (1969); Perforation of Vessels (2135); Blood Loss (2597)
Date of Event	04/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A valiant stent graft system was implanted in a patient for the endovascular treatment of a 5.9 cm in diameter thoracic aortic aneurysm.There was severe calcification in the proximal aortic neck.The patient¿s vessels were frail.There was thrombus and calcification at the proximal and distal implantation site.The diameter of the access vessel measured 7 mm.The left side was slightly less stenotic in the iliac artery but had some angulation.It was reported that the pre-operative ct did not extend below iliac bifurcation.Three months earlier the physician attempted to access the vessels however due to an unseen bare metal stents bilaterally in the femoral artery the physician could not gain access.No medtronic products were used at that time.The following week the patient had a lsa-carotid bypass.Currently, the physician elected to insert another manufacturer¿s 8 mm conduit.However, the valiant stent graft delivery system could not be advanced through the 8-mm conduit and was removed without issue from the patient.The physician removed the 8-mm conduit and replaced it with a hemishield 10-mm conduit directly to the aorta.The valiant stent graft delivery system was re-inserted and advanced to the intended landing zone, two stent rings were deployed; however before more stent rings could be deployed, the 10 mm conduit became disengaged from the artery, and the patient was bleeding out.The physician was forced to clamp the aorta to stop the bleeding.The physician repaired the perforation in the artery however when the physician unclamped the artery another perforation proximally would occur and the bleeding would return.The physician continued to clamp the patient and repair the perforation up to the renal artery.Shortly after the conduit disengaged and the patient was bleeding out, the patient coded and chest compressions were started.The valiant stent graft delivery system was still in the patient with only two stent rings deployed.When the patient became more stable- the physician completely deployed the valiant stent graft at the intended location and the delivery system was successfully removed from the patient without issue.Per the physician, the cause of the event is related to the patient¿s condition, of fragile arteries and the previously implanted bare mental stents.No additional clinical sequelae were reported and the patient is critically stable at this time.
Additional Manufacturer Narrative
Film evaluation summary: the cause of the reported implantation difficulties leading to the vessel perforation could not be determined from the pre-implant films returned.Images during implant and post-implant were not available for review.The pre-implant ct¿s confirmed that the patient had extremely calcified and diseased iliac vessels.In addition both common iliacs, including the proximal portion of the left external, appeared to have been stented.It appears likely that the patient¿s fragile vessels likely contributed to the events.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.
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.
Additional Manufacturer Narrative
Corrected information: sex, date of birth, no eval explain code.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: 6531213
• Report Number: 2953200-2017-00703
• Device Sequence Number: 16338963
• Product Code: MIH
• UDI-Device Identifier: 00643169346550
• UDI-Public: 00643169346550
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 06/02/2017

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: 07/02/2017
• Device Model Number: VAMF3838C200TU
• Device Catalogue Number: VAMF3838C200TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Initial Date Received by Manufacturer: 04/03/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 06/02/2017
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 05/24/2017; 06/08/2017; 10/03/2017
• 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: 74 YR