MAUDE Adverse Event Report: HEART VALVES SANTA ANA CONTEGRA; CONDUIT,VALVED,PULMONIC

Model Number 200

Device Problems Calcified (1077); Gradient Increase (1270); Device Operates Differently Than Expected (2913)

Patient Problems Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024); Cusp Tear (2656)

Event Date 12/30/2013

Event Type  Injury  

Manufacturer Narrative

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.At this time, a conclusion to the reported endocarditis three yrs post implant is not determined.Endocarditis that occurs more than 12 month after the procedure are called late prosthetic-valve endocarditis and are largely community-acquired versus a result of the manufacturing process of the valve.It is possible that the reported endocarditis contributed to the clinical observations 5 yrs post implant.The device was explanted and another contegra was implanted.The device was not returned for analysis.(b)(6).

Event Description

Medtronic received information that five years post implant of the pulmonary valved conduit was explanted due to stenosis, calcification, cuspal tears, and central regurgitation with a peak gradient of 59mmhg and a mean gradient of 32mmhg.Operative notes indicated patient with a history of possible endocarditis three years post implant.The conduit was removed in pieces and will not be returned.Another contegra was implanted.No further adverse patient effects were reported.

Manufacturer Narrative

Product analysis: without the return of the product, no definitive conclusion can be made regarding the clinical observation.Conclusion: the device history record review is in process, once the review is complete a supplemental report will be submitted.(b)(4).(b)(6).

Manufacturer Narrative

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

• Brand Name: CONTEGRA
• Type of Device: CONDUIT,VALVED,PULMONIC
• Manufacturer (Section D): HEART VALVES SANTA ANA; 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: 3603629
• MDR Text Key: 11626923
• Report Number: 2025587-2014-00013
• Device Sequence Number: 1
• Product Code: MWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020003
• 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: 02/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2010
• Device Model Number: 200
• Device Catalogue Number: 200H16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2007
• 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: 00006 YR