MAUDE Adverse Event Report: MEDTRONIC CARDIOVASCULAR TALENT XCELERANT BIFURCATED SG; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number AF3018C140AX

Device Problem Leak/Splash (1354)

Patient Problems Anemia (1706); Hemostasis (1895); Renal Failure (2041); Blood Loss (2597); Test Result (2695)

Event Date 03/04/2013

Event Type  Injury  

Manufacturer Narrative

Film evaluation summary: the exact cause of the alleged proximal type i endoleak, and the adverse events after the secondary intervention cannot be conclusively determined from the films provided.Pre-implant anatomy information, films at implant, and earlier post-implant films were not available for review and comparison.The 8-yr follow-up ct's showed that the talent bifurcate was sitting in the aneurysm sac.The top of the graft fabric was positioned at ~ 5 cm below the renals and was not apposed to the aortic wall.The location of bifurcate at implant was unknown, so it is unknown if the bifurcate had migrated since implant.The follow-up ct's provided were without contrast, so the alleged proximal type i endoleak cannot be assessed or confirmed.However, the proximal type i endoleak was likely due to lack of stent graft seal within the aneurysm sac.The 8-yr follow-up ct showed that the aneurysm had extended up to the aortic neck and there was no aortic neck length left.The proximal aortic neck had likely dilated due to disease progression, which may have contributed to the possible proximal type i endoleak.The reported adverse events after secondary intervention were most likely related to the procedure.No obvious issues with the endoanchors were observed.

Event Description

A talent stent graft system was implanted in the patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported that a ct scan revealed that the talent bifurcated stent graft has a proximal type i endoleak and the aneurysm was 5.3 cm in diameter.The aortic neck is 28 mm in diameter at the renal arteries, 10 mm below the renal arteries 30 mm and 15 mm to 20 mm below the renal arteries 38 mm in diameter.The physician elected to implant another manufacturer¿s 32 mm fenestrated aortic cuff and four aptus endoanchors and the proximal type i endoleak was resolved.It was reported that two of the aptus endoanchors implanted were used to secure the other manufacturer¿s aortic cuff stent graft to the talent bifurcated stent graft below the level of the proximal aortic neck.It was reported that there was worsening of thrombozytopenia and minor bleeding of the right groin that were related to the index procedure and per the investigator resolved without treatment.The patient also had an increase in creatinine value, per the investigator the event was related to the index procedure.The patient was treated with an application of nacl solution and the event resolved.No additional clinical sequelae were reported and the patient is fine.

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.

Manufacturer Narrative

Corrected information: sex.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TALENT XCELERANT BIFURCATED SG
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: paola garnica ; 3576 unocal place; santa rosa, CA 95403 ; 7075661361
• MDR Report Key: 6473525
• MDR Text Key: 72174664
• Report Number: 2953200-2017-00555
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P070027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/11/2017

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
• Device Operator: Health Professional
• Device Model Number: AF3018C140AX
• Device Catalogue Number: AF3018C140AX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2017
• Initial Date FDA Received: 04/07/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 05/11/2017
• Supplement Dates FDA Received: 05/04/2017; 06/05/2017; 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 85