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

Model Number DCS-C4-18FR

Device Problems Detachment Of Device Component (1104); Premature Activation (1484)

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

Event Date 05/22/2014

Event Type  Injury  

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, it was observed that the distal tip of the plunger was not attached to the plunger tube.The tip was not received.The dual shaft was slightly bent due to the receipt condition (loosely coiled in a biohazard bag).The handle was intact.The micro knob (thumb wheel) retracted and advanced the capsule.The macro (cursor) moved to fully advanced and retracted positions and locked in place when released.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.The head of the plunger had been detached from the plunger tube; the detachment appeared to be associated with the pull force applied on the head of the plunger while retracting the distal end through the introducer.The plunger tube was kinked and elongated.Deformation (gouge marks) on both catheter tabs appeared to be due to wear from the valve frame loop upon deployment.

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 nose cone detachment was likely caused by the nose cone getting caught on the distal edge of the introducer sheath while the attempt at valve recapture occurred.

Event Description

Medtronic received information that during the attempted implant of a transcatheter bioprosthetic valve, the valve popped out into the sinus.It was determined that the sinus was too narrow to leave the valve in that location.As the valve was being pulled back to the introducer sheath, and approximately halfway into the sheath, the valve¿s frame loops came free of the delivery catheter system (dcs) tabs and the valve deployed partially into the sheath.The dcs was removed and the sheath was pulled back, fully deploying the valve in the descending aorta, with no impact to the renal arteries.It was reported that the dcs tabs were observed to be damaged and its nose cone had separated from the rest of the dcs but remained on the guidewire.A snare was inserted through the introducer sheath and used to retrieve the nose cone into the sheath.The introducer sheath, with the nose cone inside, was then removed from the patient.A new introducer sheath was inserted and a second valve was successfully implanted with no subsequent adverse patient effects.It was reported that the patient subsequently passed away seven days after device implant from an unrelated non-cardiovascular issue.

Manufacturer Narrative

The dcs is to be returned for analysis.A supplemental report will be filed after analysis is completed.A separate report is being filed on the associated valve for the dislodgment issue.(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 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: 3878560
• MDR Text Key: 12054055
• Report Number: 2025587-2014-00397
• 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,Followup
• Report Date: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2015
• Device Model Number: DCS-C4-18FR
• Device Catalogue Number: DCS-C4-18FR
• Device Lot Number: 0007030632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/10/2014
• 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
• Treatment: (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 00082 YR