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

Model Number 200H22

Device Problem Human-Device Interface Problem (2949)

Patient Problems Calcium Deposits/Calcification (1758); Pulmonary Valve Stenosis (2024)

Event Date 08/05/2014

Event Type  Injury  

Event Description

Medtronic received information that approximately 9.25 years after implant, this pulmonary valved conduit was explanted due to calcification, moderate-severe stenosis, and a thickened pulmonic valve.The device was replaced with a pulmonary homograft and patch plasty of the pulmonary artery.Several distal remnants of this device were heavily calcified and could not be entirely removed, and were left intact in order to not fracture the left pulmonary artery.No adverse patient effects were observed following the device replacement procedure.

Manufacturer Narrative

Product analysis: the product remains was not returned, therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should the product be returned, a supplemental report will be filed following the completion of the analysis.(b)(4).

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, no explant pieces were returned for analysis.Calcification and stenosis are known adverse events and are addressed in the current device risk management file.Based on the information available, there does not appear to be any device quality issue.

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): 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: 4122607
• MDR Text Key: 4939637
• Report Number: 2025587-2014-00704
• 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: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 200H22
• Device Catalogue Number: 200H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2014
• 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: 00009 YR