MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CONTEGRA; CONDUIT,VALVED,PULMONIC

Model Number 200H18

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pulmonary Regurgitation (2023)

Event Date 08/05/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received information that 9 years and 3 months post implant of this pulmonary bioprosthetic valved conduit, pulmonary regurgitation was noted.A balloon dilatation and stenting was performed with a valve-in-valve procedure.Another model transcatheter pulmonary valve was implanted inside the bioprosthetic valved conduit.No further adverse patient effects were reported.

Manufacturer Narrative

Conclusion: no product specimen was returned for analysis.Attempts to obtain additional information and device return have been unsuccessful.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.Possible causes of the reported regurgitation include, but are not limited to, calcification, pannus or possible patient outgrowth, as the valve had been implanted for more than 9 years.However, at this time there is insufficient information to determine the root cause of the reported regurgitation.

• Brand Name: CONTEGRA
• Type of Device: CONDUIT,VALVED,PULMONIC
• 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: 5076148
• MDR Text Key: 25734591
• Report Number: 2025587-2015-00969
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2008
• Device Model Number: 200H18
• Device Catalogue Number: 200H18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2006
• 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: 00014 YR
• Patient Weight: 49