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

Model Number HG-18-90-42

Device Problems Break (1069); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A heli-fx guide, applier and endoanchors were used in the endovascular treatment of the patient for a 68mm abdominal aortic aneurysm.It was reported that during the index procedure, a 42mm heli-fx guide was used.During the withdrawal of the heli-fx applier, the physician pulled vigorously and there was a ¿catch effect¿ on the radiographic screen.The heli-fx applier was reloaded with new endoanchors and reinserted into the guider and then dislocation of the radioopaque marker was noticed.The physician immediately inserted a guide wire to remove the heli-fx guide, and the radioopaque marker was visually dislocated on fluoroscope.As per the physician the cause of the event was related to user error.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Device evaluation: the guide was returned for analysis.Deformation was visible to the inner curve of the guide tip.Delamination of the inner, exposed braid wires and a marker were observed at the guide tip.The control knob was rotated; however, the tip did not deflect.The handle was taken apart.The kevlar was observed tightly wound around the reel.On removal of the reel from the handle it was observed that the kevlar cord had been severed.It was not possible to remove the kevlar cord from the guide.The tip was cut longitudinally to expose the braid wire and kevlar cord liner.The kevlar cord was visible proximal to the tip and appeared to be severed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX TAA
• Type of Device: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC CARDIOVASCULAR SANTA ROSA; 3576 unocal place; santa rosa CA 95403
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR SANTA ROSA; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7365302
• MDR Text Key: 103448930
• Report Number: 2953200-2018-00412
• Device Sequence Number: 1
• Product Code: OTD
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: HG-18-90-42
• Device Catalogue Number: HG-18-90-42
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2017
• 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