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

Model Number DCS-C4-18FR

Device Problems Positioning Failure (1158); Device Operates Differently Than Expected (2913)

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

Event Date 06/09/2015

Event Type  malfunction  

Event Description

Medtronic received information that during the implant of a 26 mm transcatheter bioprosthetic valve, when the micro knob of this delivery catheter system (dcs) was turned to start the deployment of the valve, the capsule moved up to 2 mm and then it would not move any further.It was reported that there was no "clicking" heard.Per the instructions for use (ifu), upward pressure was applied, to assist with deployment.The capsule still would not move.The delivery catheter system (dcs) was taken out of the body and without doing anything differently, the valve was able to be deployed on the table.A new dcs was used to implant the valve.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: the product has not been returned for analysis, however, the return is anticipated.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

Upon receipt at medtronic's quality laboratory, the delivery catheter system (dcs) was received tightly coiled in a plastic bag contained in an open biohazard bag.The dual shaft showed deformation which appeared to be the result of the receipt condition.A kink was observed on the dual shaft and appeared to be associated with the receipt condition.The handle appeared intact.The micro knob (thumb wheel) appeared to retract and advanced the capsule.The macro (cursor) moved to fully advance and retracted positions and locked in place when released.The capsule was able to fully advanced and retracted.The distal tip of the capsule seated flushed against the plunger tip when fully advanced.Two large kinks were observed on the distal and proximal ends of the capsule and were associated with the receipt condition.The distal end of the capsule appeared flattened with creases adjacent to and on the radiopaque marker band.This may be the result of retracting an unloaded capsule through the introducer.Minor buckling of the material was observed at the proximal end of the capsule.The plunger tube was bent at the hub transition with a small kink adjacent to the middle of the tube.Both are likely associated with the receipt condition.No gouge marks were observed on the catheter tabs.

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: 4891737
• MDR Text Key: 6017214
• Report Number: 2025587-2015-00725
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2015
• Device Model Number: DCS-C4-18FR
• Device Catalogue Number: DCS-C4-18FR
• Device Lot Number: 0007383371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2015
• Initial Date FDA Received: 07/06/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/09/2015
• Supplement Dates FDA Received: 10/27/2015; 10/27/2015; 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2014
• 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