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

Model Number DCS-C4-18F-US

Device Problems Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

Patient Problem Aortic Insufficiency (1715)

Event Date 02/16/2016

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without return of the device, a conclusive cause cannot be determined.(b)(4).

Event Description

Medtronic received information that during the implant of this 31 mm transcatheter bioprosthetic valve, the valve could not be released from the tabs.The specified manipulation was used following which the tabs released simultaneously, however, the valve dislodged into the sinus of valsalva (sov).A second 31 mm valve was successfully implanted.Trace aortic insufficiency was noted.No adverse patient effects were reported.The delivery catheter system (dcs) was discarded.

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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5483382
• MDR Text Key: 39769232
• Report Number: 2025587-2016-00291
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2016

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: Physician
• Device Expiration Date: 08/10/2016
• Device Model Number: DCS-C4-18F-US
• Device Catalogue Number: DCS-C4-18F-US
• Device Lot Number: 0007682615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2016
• Initial Date FDA Received: 03/07/2016
• Supplement Dates Manufacturer Received: 02/16/2016
• Supplement Dates FDA Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/11/2015
• 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: 00075 YR