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

Model Number DCS-C4-18FR

Device Problems Difficult or Delayed Positioning (1157); Device Operates Differently Than Expected (2913)

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

Event Date 06/19/2014

Event Type  Injury  

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve ((b)(4)) the valve was deployed to 2/3 and at a depth of 4mm.The frame loops would not release from the delivery catheter system (dcs).The specified manipulation was performed to release the valve.Proper technique was utilized to pull tension from the wire and push forward with the dcs to relieve catheter tension.By turning the dcs handle and pushing forward the tabs released.However it was noted on the aortogram that the valve had moved into a supra annular position with severe paravalvular leak (pvl).A snare was used to move the valve into the ascending aorta.A snare was used to hold the first valve as a second valve ((b)(4)) was introduced into the patient.The snare was released to insert the pigtail however, the patient became hypotensive and the pigtail could not be placed.During the implant of the second valve, there was no angiographic point of reference for the annulus.A fluoroscopic anatomical landmark was used to judge the implant depth and the second valve was deployed to 2/3.The valve was low and the physician pulled to position the valve higher, but it also moved out of the annulus.At that time, the patient arrested and cpr and temporary pacing was initiated.During cpr the rhythm converted to complete heart block (chb) with a junctional rhythm.The second valve was retrieved from the patient and a third valve ((b)(4)) was successfully deployed with mild pvl.

Manufacturer Narrative

Product analysis: the product was not returned, therefore no product analysis can be performed.Conclusion: a formal investigation has been initiated to further investigate for root cause(s) of reports of deployment issues.(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.The device was not returned for analysis; from the available information, a conclusive cause for the deployment/frame loop release difficulty could not be determined.Potential factors contributing factors include the orientation of the dcs tab/valve frame loop against the patient¿s anatomy, and the angle of deployment in which the dcs tab is rotated in the frame loop.This issue is a known potential risk, and the instructions for use provides guidance on releasing the frame loop from the delivery system.Inaccurate delivery is often influenced by patient anatomy and user technique.Based on the reported information, it is likely that the motion applied to the dcs in order to release the tabs had an impact on the positioning of the valve.However, a root cause could not be determined from the available information.

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: 3909613
• MDR Text Key: 4520810
• Report Number: 2025587-2014-00437
• 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,Followup
• Report Date: 12/09/2014

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: 03/13/2015
• Device Model Number: DCS-C4-18FR
• Device Catalogue Number: DCS-C4-18FR
• Device Lot Number: 0007068081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 07/02/2014
• Supplement Dates Manufacturer Received: Not provided; 12/09/2014
• Supplement Dates FDA Received: 12/15/2014; 09/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/13/2014
• 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