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

Model Number DCS-C4-18FR

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/04/2015

Event Type  Injury  

Manufacturer Narrative

Conclusion: vascular access related complications, such as stenosis, are known potential adverse effects per the instructions for use (ifu) and do not indicate a manufacturing related issue.In this case, it was reported that the stenosis was located at the left common iliac artery and the delivery catheter system (dcs) access site had been the right common iliac artery, so the dcs was not related to the stenosis.

Event Description

Medtronic received information that approximately three months following the implant of a transcatheter bioprosthetic valve using this delivery catheter system (dcs), left common iliac artery stenosis was noted.Percutaneous transluminal angioplasty (pta) was performed.No additional adverse patient effects were reported.

Manufacturer Narrative

The device will not be returned for analysis, as it was discarded by the customer.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

Additional information was received indicating that the observed stenosis was at the left common iliac artery; the delivery catheter system (dcs) and valve were introduced utilizing the right common iliac artery.It was reported that the stenosis was not related to the corevalve or its implantation.

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: 4739665
• MDR Text Key: 14089094
• Report Number: 2025587-2015-00493
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/27/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2015
• Device Model Number: DCS-C4-18FR
• Device Catalogue Number: DCS-C4-18FR
• Device Lot Number: 0007027702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2015
• Initial Date FDA Received: 04/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 07/27/2015
• Supplement Dates FDA Received: 06/05/2015; 08/05/2015; 09/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/07/2014
• 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
• Patient Age: 00074 YR