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 Perivalvular Leak (1457); Inaccurate Delivery (2339); Separation Failure (2547); Activation Failure (3270)

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

Event Date 08/21/2015

Event Type  Injury  

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual inspection of the delivery catheter system (dcs) indicated that the luer end cap was attached to the guidewire lumen port.Dry blood was observed along the device.Blood was observed in the capsule.The handle was intact.The micro knob (thumb wheel) retracted and advanced the capsule.The macro (cursor) moves to the fully advanced and retracted positions and locks in place when released.A large gouge was observed on the last thread of the handle drive screw.The distal tip of the capsule seated flush against the plunger tip when fully advanced.Several kinks or telescoping were observed along the capsule between the proximal and distal ends.A kink was observed on the proximal end of the capsule.Tiny stress marks were observed on the distal tip of the capsule along the radiopaque marker band.A small kink was noted on the plunger tube adjacent to the plunger hub transition.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.A separate report has been filed regarding the valve.(b)(4).

Event Description

Medtronic received information that prior to the implant of a transcatheter bioprosthetic valve, during loading, the valve outflow struts appeared to fold in on themselves.The valve was removed from the delivery catheter system (dcs) and successfully reloaded.An attempt was made to implant the valve through a pre-existing dissection into a chronic 29 mm homograft.Severe tortuosity of the patient anatomy was reported.During deployment, the dcs capsule was unable to completely release the outflow tabs of the valve.It was reported that there was difficulty with the capsule coming back to release the valve tabs from the stainless steel pins.After the specified manipulation to release the tabs, the valve released from the dcs but was implanted high.The outflow section of the valve did not fully expand due to anatomy and moderate paravalvular leak (pvl) was noted.Balloon aortic valvuloplasty (bav) was performed.A second transcatheter bioprosthetic valve was loaded onto a new dcs and successfully implanted.The pvl was reduced to mild.No adverse patient effects were reported.

Manufacturer Narrative

A simulated experiment to recreate the issue was carried out on this unit in two separate testing sites.The testing in one site successfully recreated the deployment issue however it was not possible to repeat this in the other testing site despite multiple attempts.A thorough investigation was performed by the manufacturing site, which indicated that all components and bonds were within specification and no issues with the assembly of the devices were found.Deployment difficulties due to inability to retract the capsule can be related to several mechanisms such as inadequate loading by user, excessive forces on the system due to patient anatomy, or a combination of both.Without return of procedure imaging for review, an assignable root cause cannot be determined at this time.(b)(4).

• 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: 5074895
• MDR Text Key: 25691770
• Report Number: 2025587-2015-00966
• 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: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/28/2016
• Device Model Number: DCS-C4-18F-US
• Device Catalogue Number: DCS-C4-18F-US
• Device Lot Number: 0007631458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2015
• 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: 00067 YR
• Patient Weight: 93