MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION ACCUTRAK DELIV SYS 23MM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number DCS-C4-18FR-23MM

Device Problem Occlusion Within Device (1423)

Patient Problem Occlusion (1984)

Event Type  Injury  

Event Description

Medtronic received information that following a successful valve-in-valve procedure performed with placing a transcatheter bioprosthetic valve (corevalve) into a previously implanted (11+ years) stenotic bioprosthetic valve, there was occlusion of the right common and superficial femoral arteries, resolved with surgical repair of both arteries.A thrombectomy was also performed on the right superficial femoral artery.

Manufacturer Narrative

Product analysis: no product was returned, therefore no product analysis can be performed.Conclusion: 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.It is unknown whether the reported occlusion was related to patient condition and/or closure technique as no deficiencies were alleged against the device.The issue was resolved with surgical repair of the artery.As a thrombectomy was performed on the same vessel, it is likely that thrombus caused or significantly contributed to the occlusion.No other adverse effects were reported.(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACCUTRAK DELIV SYS 23MM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: mike gaffney ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635265629
• MDR Report Key: 3722093
• MDR Text Key: 4309270
• Report Number: 2025587-2014-00180
• Device Sequence Number: 1
• Product Code: LWR
• 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
• Report Date: 03/12/2014

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: Other
• Device Expiration Date: 10/25/2014
• Device Model Number: DCS-C4-18FR-23MM
• Device Catalogue Number: DCS-C4-18FR-23MM
• Device Lot Number: 0006915386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2014
• Initial Date FDA Received: 04/02/2014
• Supplement Dates Manufacturer Received: 03/12/2014
• Supplement Dates FDA Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/25/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 69