MAUDE Adverse Event Report: MEDTRONIC CARDIOVASCULAR ENDO ANCHOR SYSTEM - HELI-FX AAA; ENDOVASCULAR SUTURING SYSTEM

Model Number SA-85

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2017

Event Type  malfunction  

Manufacturer Narrative

Film review summary review of a single returned non-contrast angiogram during implant revealed that 3 endoanchors had been implanted along the proximal/right wall of an endurant bifurcate.In addition, a partial (and likely fractured) section of an anchor was seen implanted along the left wall of the bifurcate.The fractured anchor was ~2 full turns in length, and the tail end of the fractured anchor was not seen in the films.The guide was positioned just above the broken anchor and was deflected ~90 deg toward the left-lateral wall of the bifurcate.No other obvious guide or stent graft issues were observed.A photograph of the tail end of the fractured anchor which had been removed from the patient was also returned; the anchor appeared to have fractured at the weld.The exact cause of the anchor fracture could not be determined from the single returned film and photograph.Other than the reported calcification, details of the anatomy at implant is unknown, and pre-implant ct¿s were not available for a comprehensive assessment of the patient¿s anatomy.In addition, complete images during implant, including films during the fracture event, were not available for review.It is possible that implanting into the reported calcified vessel may have contributed to the anchor fracture.

Event Description

A heli-fx was used as an accessory device for the endovascular treatment of a patient.However, it was reported that when the physician was deploying the third endoanchor in the proximal neck, the endoanchor fractured during the second phase of deployment.It was reported that, once the physician hit the button to deploy the second stage, the applier made a loud sound and the endoanchor looked as if it had straightened and then broke in half.It was reported that, the distal end of the endoanchor remained engaged through the graft and into the calcium with the proximal part of the endoanchor still in the applier.The physician retracted the applier back and could remove everything through the sheath with no issue reported.The physician reported that the cause of the fracture was, most likely due to calcium in the artery.No clinical sequelae were reported and the patient is fine.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX AAA
• Type of Device: ENDOVASCULAR SUTURING SYSTEM
• 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: ibrahim ibrahim ; 3576 unocal place; santa rosa, CA 95403 ; 7075917650
• MDR Report Key: 6998775
• MDR Text Key: 92046537
• Report Number: 2953200-2017-01695
• Device Sequence Number: 1
• Product Code: OTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2017
• 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 Age: 66 YR