MAUDE Adverse Event Report: MEDTRONIC SUNNYVALE/APTUS ENDOSYSTEMS ENDO ANCHOR SYSTEM - HELI-FX TAA; ENDOVASCULAR SUTURING SYSTEM

Model Number HG-18-90-32

Device Problems Difficult to Insert (1316); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2017

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: ha-18-114 sn (b)(4), expiration date: 2019-02-28, (b)(4).Device evaluation summary: the reported complaint could not be confirmed since the event took place in-vivo and since the guide was manually cut during the procedure.Due to the damaged incurred during cutting of the guide, the root cause of the event could not be conclusively determined.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.

Event Description

A heli-fx applier was used as prophylactic with an endurant stent graft system in a patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported that the patient¿s infrarenal neck is growing and the physician decided to prophylactically secure the stent graft to prevent further growth of the infrarenal neck, and prevent a type i endoleak.The guide and applier were prepared intended.The intention was to place the first endoanchor.The anchor was partially deployed as (step one) and it was determined that this was the desired position.The physician wanted to complete the deployment of the endoanchor as (step two), however, the applier did not work and the blue light was lighting.The endoanchor was able to be removed by twisting the applier counter clockwise.Another applier was then used to attempt to complete the case.After two anchors were placed and the guide was in a 90-degree angle to place another endoanchor, extreme resistance was felt.The applier had been inserted to the tip of the guide; however, it was impossible to advance or withdraw the applier.The whole system was removed from the patient.The applier was stuck in the guide.It was possible to use the applier, but it was impossible to advance or withdraw the applier.A third applier was not available the decision was made to cut open the tip of the guide and removed the applier.The applier was checked and it was not damaged.Another guide was used to complete the procedure as planned.No abnormal use and handling of the device was observed.The physician stated the cause of the event is device related.No clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

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 SUNNYVALE/APTUS ENDOSYSTEMS; 271 gibraltar drive; sunnyvale CA 94089
• Manufacturer (Section G): MEDTRONIC SUNNYVALE/APTUS ENDOSYSTEMS; 271 gibraltar drive; sunnyvale CA 94089
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway, CA ; 7075661361
• MDR Report Key: 6606293
• MDR Text Key: 76517226
• Report Number: 2953200-2017-00897
• Device Sequence Number: 1
• Product Code: OTD
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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-18-90-32
• Device Catalogue Number: HG-18-90-32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2017
• Initial Date FDA Received: 06/01/2017
• Supplement Dates Manufacturer Received: 05/08/2017; 11/22/2019
• Supplement Dates FDA Received: 10/04/2017; 12/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2017
• 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 Age: 72 YR
• Patient Weight: 91