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

Model Number 200H18

Device Problems Calcified (1077); Insufficient Information (3190)

Patient Problems Calcium Deposits/Calcification (1758); Pulmonary Valve Stenosis (2024); No Information (3190)

Event Date 08/29/2018

Event Type  Injury  

Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that six years post implant of this 18mm pulmonary bioprosthetic valved conduit implanted in a six year old pediatric patient, the conduit was explanted and replaced with a 20mm valved conduit.The reason for explant is unknown.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that the valve was explanted due to stenosis, heavy calcification and conduit adherence to the leftward aspect of the ascending aorta.No additional adverse patient effects were reported.  patient weight added in section.Patient codes updated in section.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic received additional information that the valve was explanted due to heavy calcification and conduit adherence to the leftward aspect of the ascending aorta.No additional adverse patient effects were reported.  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 VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7930624
• MDR Text Key: 122513071
• Report Number: 2025587-2018-02628
• Device Sequence Number: 1
• Product Code: MWH
• UDI-Device Identifier: 00613994600301
• UDI-Public: 00613994600301
• Combination Product (y/n): N
• PMA/PMN Number: H020003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2021

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: 11/18/2013
• Device Model Number: 200H18
• Device Catalogue Number: 200H18
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 10/03/2018
• Supplement Dates Manufacturer Received: 10/01/2018; 02/10/2020
• Supplement Dates FDA Received: 10/03/2018; 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR
• Patient Weight: 28