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

Model Number 200SH20

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

Patient Problems Pulmonary Regurgitation (2023); No Information (3190)

Event Date 07/08/2019

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.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 7 years post implant of this bioprosthetic pulmonary valved conduit implanted in a (b)(6) year old patient, a transcatheter pulmonary valve (tpv) was implanted valve-in-valve.The reason for valve replacement was not reported.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received information that the reason for replacement was due to moderate to severe regurgitation as well as calcification.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: 8852307
• MDR Text Key: 153074590
• Report Number: 2025587-2019-02447
• Device Sequence Number: 1
• Product Code: MWH
• UDI-Device Identifier: 00613994600202
• UDI-Public: 00613994600202
• 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
• Report Date: 08/14/2019

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: 06/16/2014
• Device Model Number: 200SH20
• Device Catalogue Number: 200SH20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/08/2019
• Initial Date FDA Received: 08/01/2019
• Supplement Dates Manufacturer Received: 08/12/2019
• Supplement Dates FDA Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR
• Patient Weight: 43