MAUDE Adverse Event Report: MEDTRONIC 3F THERAPEUTICS, INC. THV 1000-21 3F AORTIC BIO 21MM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 1000-21

Device Problems Gradient Increase (1270); Occlusion Within Device (1423)

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

Event Date 10/07/2014

Event Type  Injury  

Event Description

Medtronic received information that this bioprosthetic heart valve was explanted approximately 33.5 months after implant.A follow-up echocardiogram at 31 months post-implant had shown high gradients and aortic stenosis.No subsequent adverse patient effects were reported.

Manufacturer Narrative

It was not reported whether the device would be returned for analysis.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.(b)(4).

Manufacturer Narrative

The echocardiogram report noted the valve anatomy and hemodynamics suggested prosthetic valve stenosis, possible thrombosis and/or early valve deterioration.Limited leaflet calcification was noted.(b)(4).

Manufacturer Narrative

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

• Brand Name: THV 1000-21 3F AORTIC BIO 21MM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC 3F THERAPEUTICS, INC.; 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: 4467048
• MDR Text Key: 5401290
• Report Number: 2025587-2015-00101
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2014
• Device Model Number: 1000-21
• Device Catalogue Number: 1000-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2015
• Was Device Evaluated by Manufacturer?: No
• 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: 00067 YR