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

Model Number DCS-C4-18FR

Device Problems Positioning Failure (1158); Device Operates Differently Than Expected (2913)

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

Event Date 02/11/2014

Event Type  malfunction  

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the capsule of the delivery catheter system (dcs) was deployed about 5mm and the micro knob started clicking.The operator placed upward pressure on the macro slider, but the clicking continued.The whole system was removed from the patient.The valve was reloaded onto another dcs from the same lot, and the valve was successfully implanted.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: the product has been received at medtronic's quality laboratory and continues to undergo analysis.Conclusion: following completion of the analysis, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, the delivery catheter system (dcs) handle was intact.The micro knob (thumb wheel) retracted and advanced the capsule.The macro (cursor) moved to fully advanced and retracted positions and locked in place when released.The distal tip of the capsule seated flush against the plunger tip when fully advanced.A kink was observed on the proximal end of the capsule.Tiny abrasions and stress marks were observed along the distal tip of the capsule.The plunger tube was bent adjacent to the plunger tube/plunger hub.The distal end of the plunger tube, at the plunger tip transition, showed slight necking (stretching).The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Subsequently, an assessment of the complaint unit, including a deployment simulation, was performed at the device manufacturing site.After 20 millimeters of dcs cursor movement clicking was encountered.The valve was able to be deployed by lifting the cursor per the instructions for use technique.It could not be determined why the operator's use of this technique was not successful but use of the technique during laboratory testing resulted in deployment.

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: 3658617
• MDR Text Key: 15328206
• Report Number: 2025587-2014-00091
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2014

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: 11/28/2014
• Device Model Number: DCS-C4-18FR
• Device Catalogue Number: DCS-C4-18FR
• Device Lot Number: 0006958386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2014
• Initial Date FDA Received: 03/04/2014
• Supplement Dates Manufacturer Received: Not provided; 07/09/2014
• Supplement Dates FDA Received: 07/28/2014; 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2013
• 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 Age: 00064 YR