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

Model Number DCS-C4-18F-US

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/08/2014

Event Type  malfunction  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.(b)(4).

Event Description

Medtronic received information via a warranty form that during the implant of this transcatheter bioprosthetic valve, an audible clicking of the delivery catheter system (dcs) was noted.The dcs and valve were successfully removed from the patient with no adverse patient effects 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 HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5605475
• MDR Text Key: 43997282
• Report Number: 9612164-2016-00409
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2014

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?: No
• Device Operator: No Information
• Device Expiration Date: 08/19/2015
• Device Model Number: DCS-C4-18F-US
• Device Catalogue Number: DCS-C4-18F-US
• Device Lot Number: 0007264382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2014
• Initial Date FDA Received: 04/25/2016
• Supplement Dates Manufacturer Received: 12/22/2014
• Supplement Dates FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/19/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR