MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION ACCUTRAK DELIVERY CATHETER SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number DCS-C4-18FR

Device Problems Difficult or Delayed Positioning (1157); Premature Activation (1484); Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2014

Event Type  malfunction  

Event Description

Medtronic received information that during deployment of this transcatheter bioprosthetic valve, the valve moved from its targeted location.When removing the valve and delivery catheter system (dcs) from the patient, the valve tabs disengaged from the dcs and the valve was released at the level of the right renal artery.The valve was snared into a lower position in the right common iliac to ensure that no major vessels were obstructed.Angiographic films confirmed no vascular events or vascular obstruction were present.The procedure was completed and no valve was implanted in the annular position.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: based on the information provided, the root cause for this report could not be established.Positioning is dependent on patient anatomy as well as user technique.Potential factors that can influence implant position include tension applied on the delivery catheter system (dcs) during positioning, calcification levels in the native vessel, compliance of the aorta and native vessels.The procedure was completed with no valve implanted in the annular position.No adverse patient effects were reported.(b)(4).

Manufacturer Narrative

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

• Brand Name: ACCUTRAK DELIVERY CATHETER SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e. deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: mike gaffney ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635265629
• MDR Report Key: 3683952
• MDR Text Key: 4237893
• Report Number: 2025587-2014-00128
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2014
• Device Model Number: DCS-C4-18FR
• Device Catalogue Number: DCS-C4-18FR
• Device Lot Number: 0006957166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/27/2013
• 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