MAUDE Adverse Event Report: MEDTRONIC HEART VALVES 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 01/29/2014

Event Type  malfunction  

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve; after rotating the micro knob several times during deployment of the valve, the capsule would not move to deploy the valve.The entire system including the dcs and valve was removed from the patient.The valve was loaded on a new catheter.Again, the capsule would not move to deploy the valve after several turns of the micro knob.The dcs and the valve were removed from the patient.A new catheter was used along with a new valve.During deployment and the micro knob still had difficulty moving the capsule for deploying the valve.The implanter used the macro knob to deploy the valve, stopping at the 2/3 mark, tension was applied to the system and the valve was fully deployed; however it dove 8 mm and was snared into an ideal position of 4mm.The patient remained stable and was reported to be doing well.

Manufacturer Narrative

Product analysis: the product has been returned to medtronic's quality laboratory and continues to undergo analysis.Conclusion: at the conclusion of the analysis, a follow up report will be submitted.(b)(4).

Manufacturer Narrative

The lot 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.Upon receipt at medtronic¿s quality laboratory, the 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.Damage noted on the drive screw was consistent with damage caused during clicking of the unit.Simulation testing was completed with a 31mm valve, with no clicking noted during valve loading.During deployment, after 20 millimeters of cursor travel the unit clicked.At that point, upward pressure was applied to the cursor, resulting in complete deployment.The clicking complaint was confirmed.However, it was not reported that the user applied the technique of lifting the cursor as prescribed in the instructions for use (ifu).A conclusive cause could not be determined, as the difficulty reported by the user may be related to not following the ifu mitigation.

• Brand Name: ACCUTRAK DELIVERY CATHETER SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES; 1851 e. deere ave; santa ana CA 95702
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 3643224
• MDR Text Key: 4185080
• Report Number: 2025587-2014-00067
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2014
• Device Model Number: DCS-C4-18FR
• Device Catalogue Number: DCS-C4-18FR
• Device Lot Number: 0006919910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2014
• Initial Date FDA Received: 02/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2013
• 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
• Patient Age: 00080 YR