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

Model Number DCS-C4-18FR

Device Problem Premature Activation (1484)

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

Event Date 01/21/2014

Event Type  Injury  

Manufacturer Narrative

Upon receipt at medtronic's quality laboratory, kinks and telescoping were observed along the delivery catheter system (dcs) capsule and kinks were observed at the proximal end of the capsule.The handle was intact.The micro knob (thumb wheel) retracted and advanced the capsule.The macro slider (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.Deformation (gouge marks) on both catheter tabs appeared to be due to wear from the valve frame loop upon deployment.The device 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 observed telescoping and the kinks on the capsule are consistent historically with devices tracked over an aortic arch and are not indicative of a device issue.The deformation of the dcs tabs showed evidence of a tensile force applied, most likely from the frame loops of the valve.The analysis results confirm the clinical observation that the user attempted to retrieve a partially-deployed valve (one that is not fully captured in the capsule) that resisted retrieval, and the user applied tension in pulling back the dcs in the retrieval attempt, which caused damage to the dcs tabs.This damage to the dcs tabs, along with continued tension on the system, allowed the valve frame loops to release from the tabs.The dcs is not designed to be a retrieval device; the instructions for use (ifu) states: "once deployment is initiated, retrieval of the bioprosthesis from the patient (e.G., use of the catheter) is not recommended.".

Event Description

Medtronic received information that during the implant of this 26mm transcatheter bioprosthetic valve, the valve was positioned too high after 1/3 deployment and the decision was made to remove the valve.The valve was being removed when the valve inadvertently deployed at the renal level.It was reported that upon removal of the delivery catheter system (dcs) visual inspection of the tabs revealed they did not appear normal (deformed).The first valve was snared and positioned distal to the renal arteries.A second valve was successfully implanted and no adverse patient effects were reported.

Manufacturer Narrative

The product has not yet been returned.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.Should the product be returned, a follow-up report will be submitted.(b)(4).

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 DEVISION; 1851 east 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: 3643102
• MDR Text Key: 11865796
• Report Number: 2025587-2014-00064
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2014
• Device Model Number: DCS-C4-18FR
• Device Catalogue Number: DCS-C4-18FR
• Device Lot Number: 0006943430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2013
• 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