MAUDE Adverse Event Report: MEDTRONIC 3F THERAPEUTICS, INC. THV 1000-23 3F AORTIC BIO 23MM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 1000

Device Problems Gradient Increase (1270); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Aortic Regurgitation (1716); Chest Pain (1776); Fatigue (1849)

Event Date 09/09/2014

Event Type  Injury  

Event Description

Medtronic received information that three years following the implant of this open pivot mechanical valve, an echocardiogram showed a peak gradient of 43 mmhg, but good performance of the valve.These findings were consistent with the transesophageal echocardiogram (tee) from the previous year.The patient reported increasing fatigue and vague anterior chest pain with exertion.Trace aortic regurgitation was found.The physician instructed the patient to try to lose weight.Forty (40) months following implant the valve was explanted due to patient-prosthesis mismatch.It was reported that gross visual examination of the valve and aortic root were normal; no other pathology was noted.

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.(b)(4).

Manufacturer Narrative

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

• Brand Name: THV 1000-23 3F AORTIC BIO 23MM
• 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: 4519039
• MDR Text Key: 5530111
• Report Number: 2025587-2015-00216
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P060025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/23/2015

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: 06/08/2015
• Device Model Number: 1000
• Device Catalogue Number: 1000-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2015
• Initial Date FDA Received: 02/16/2015
• Supplement Dates Manufacturer Received: 01/23/2015
• Supplement Dates FDA Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2011
• 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: 00057 YR
• Patient Weight: 93