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 01/29/2014

Event Type  malfunction  

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the capsule of this delivery catheter system (dcs) would not retract due to clicking of the micro knob.The macro knob was pushed up with the thumb, without success in moving the capsule.The dcs was removed from the patient and another dcs of the same lot number was used with a successful implant.There was no impact to the patient associated with this event.The dcs was discarded.

Manufacturer Narrative

Product analysis: no product was returned, therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.No adverse patient effects were reported.

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: 3662834
• MDR Text Key: 4198813
• Report Number: 2025587-2014-00097
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2014

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: 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: 01/29/2014
• Initial Date FDA Received: 03/06/2014
• Supplement Dates Manufacturer Received: 01/29/2014
• Supplement Dates FDA Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 00082 YR
• Patient Weight: 64