MAUDE Adverse Event Report: MEDTRONIC-SUNNYVALE/APTUS ENDOSYSTEMS ENDO ANCHOR SYSTEM - HELI-FX TAA; CATHETER, PERCUTANEOUS

Model Number HA-18-114

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 10/12/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The aptus applier was selected for prophylactic treatment.It was reported that during the index procedure, upon deployment of the first aptus endoanchor in the distal arch, the endoanchor came loose.The physician was able to snare the endoanchor and remove it from the patient.The diameter of the proximal landing zone was 40-42mm.No further treatment was performed and the patient did not have any complications.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Evaluation of the returned device has been completed.The exact cause of the mis-deployed endoanchor cannot be definitely determined although the deformation suggests the endoanchor encountered significant resistance during deployment.Based on historical analysis of similar complaints, there is no evidence of a material defect that would have been contributory to the deformation.Conditions that have historically been identified as causes of deployment resistance include: positioning of the heli-fx applier at an angle relative to the vessel wall during deployment, endograft/cuff material infolding or oversizing, and calcification in the area of deployment as well as not maintaining adequate pressure/apposition during deployment.If the heli-fx applier is not positioned perpendicular to the vessel wall with sufficient forward pressure and proper apposition or in an area of calcium or highly concentrated or loose endograft/cuff material, it increases the likelihood the endoanchor will encounter resistance as it is deployed.The excess torque is transmitted directly to the endoanchor leading to its deformation.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX TAA
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC-SUNNYVALE/APTUS ENDOSYSTEMS; 271 gibraltar dr; sunnyvale CA 94089
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 5206292
• MDR Text Key: 30578034
• Report Number: 2953200-2015-01906
• Device Sequence Number: 1
• Product Code: DQY
• 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,Followup
• Report Date: 11/17/2015

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 Expiration Date: 07/31/2017
• Device Model Number: HA-18-114
• Device Catalogue Number: HA-18-114
• Device Lot Number: 49372012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2015
• Initial Date FDA Received: 11/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2015
• 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: 00075 YR