MAUDE Adverse Event Report: MEDTRONIC SUNNYVALE/APTUS ENDOSYSTEMS ENDO ANCHOR SYSTEM - HELI-FX TAA; LASER THERAPY PRODUCT

Model Number HA-18-114

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 03/12/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A heli-fx applier and endoanchors were used in the endovascular treatment of a patient in conjunction with a valiant stent graft system for a thoracic aortic aneurysm.It was reported during the index procedure that the valiant was being implanted distal to a previously implanted stent graft to extend the seal zone in a reintervention procedure.2 endoanchors were implanted in an ap direction successfully but on implantation of the 3rd endoanchor, it appeared to bounce off the m stent and was partially deployed into the stent graft.It was observed that a portion of the endoanchor broke off and this was successfully snared out.Another endoanchor was deployed and when imaged this appeared to have been implanted outside of the stent graft.After a total of 10 endoanchors had been implanted.A review was performed to ensure no stent graft tear was present after the observation of the stent graft had been deployed outside of the stent graft but there was no tear or leak observed.As per the physician the cause of the event cannot be determined.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Film evaluation summary: the cause of the events could not be determined from the films provided.The cause of the reported reduced distal seal zone of the initially implanted valiant could not be determined.Review of a limited angiogram study during the 2015 implant revealed that a single valiant stent graft had been implanted in the patient¿s thoracic.Multiple endoanchors (>10) also were seen having been implanted into the distal 3cm length of the valiant.The distal stent graft position relative to the visceral vessels could not be determined, and no clear endoleak or any other issues were observed from the limited study returned.The returned 2018 pre-intervention images were non-contrast; therefore, no assessment of any potential endoleak could be performed, and the distal stent graft position relative to the visceral vessels also could not be determined.The exact cause of the reported partial endoanchor deployment and fracture also could not be determined from the films.Angiograms during the segments of the intervention were returned.Several non-contrast still images revealed that an additional valiant stent graft had been implanted, extending several cm¿s distal to the previously implanted device.Two (2) endoanchors were initially seen having been deployed, and the guide and likely single mal-deployed anchor were then seen along the patient¿s right side of the distal stent graft.The guide was angulated ~90 deg to the right, and after straightening the guide another image showed what appeared to be an anchor positioned outside the right side of the stent graft, as well as portion of another (or same) anchor positioned near the distal stent graft margin.Cine images during anchor deployment were not seen, and it is unclear if these mal-deployed anchors were implanted in the aorta or floating.Final angiogram during contrast injection revealed no clear endoleak or any other obvious issues.Analysis of the returned films did not reveal any device or anatomical characteristics that could explain the reported event, and lack of ct¿s did not allow for a thorough assessment of the patient¿s anatomy.A device issue cannot be ruled out as a potential cause of the partial endoanchor deployment and fracture.The guide and/or broken anchor is expected to be returned for analysis, and the results will be summarized in a separate report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation summary: there was no damage observed to the device or the endoanchor housing.Visual inspection confirmed there was no endoanchor loaded in the applier.The handle was opened, and no fluid or blood was observed within the handle.No corrosion was observed to the circuit board or connector pins.All wires and connectors within the handle appeared to be intact and properly connected.The battery was removed and measured 7.19v.A new battery was attached, and the unit powered up with the blue error light flashing, the forward light unresponsive and the back light flashing.The device was restarted in factory mode with the blue error light on, forward light flashing, back light on.The inner tip mechanism did not rotate when the forward and back buttons were pressed.However, the applier shaft did rotate, and twisting was observed on the shaft.It was not possible to flush water through the shaft indicating the presence of congealed blood within the device.The shaft was cut back; congealed blood was visible inside the shaft.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX TAA
• Type of Device: LASER THERAPY PRODUCT
• Manufacturer (Section D): MEDTRONIC SUNNYVALE/APTUS ENDOSYSTEMS; 271 gibraltar dr; sunnyvale; california 94089
• Manufacturer (Section G): MEDTRONIC SUNNYVALE/APTUS ENDOSYSTEMS; 271 gibraltar dr; sunnyvale; california 94089
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7403436
• MDR Text Key: 104588470
• Report Number: 2953200-2018-00509
• Device Sequence Number: 1
• Product Code: OTD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K140036
• 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
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: HA-18-114
• Device Catalogue Number: HA-18-114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2017
• 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