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

Model Number 200SH18

Device Problems Calcified (1077); Gradient Increase (1270)

Patient Problems Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024)

Event Date 08/23/2018

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 13 years and 6 months post implant of this pulmonary valved conduit in a (b)(6) year old pediatric patient, an transcatheter pulmonary bioprosthetic valve (tpbv) was implanted valve-in-valve due to mild regurgitation, moderate stenosis, and increased gradients.The physician reported the conduit was thickened with some mobile tissue present.No additional adverse patient effects were reported. .

Manufacturer Narrative

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

Manufacturer Narrative

Description of the event problem updated.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 13 years and 6 months post implant of this pulmonary valved conduit in a (b)(6) year old pediatric patient, a transcatheter pulmonary bioprosthetic valve (tpbv) was implanted valve-in-valve due to mild regurgitation, moderate stenosis, and increased gradients.The physician reported the conduit was thickened due to heavy calcification with some mobile tissue present.No additional adverse patient effects were reported.

• Brand Name: CONTEGRA
• Type of Device: CONDUIT,VALVED,PULMONIC
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7882400
• MDR Text Key: 120456419
• Report Number: 2025587-2018-02438
• 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: 09/24/2018

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: 12/11/2006
• Device Model Number: 200SH18
• Device Catalogue Number: 200SH18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 09/17/2018
• Supplement Dates Manufacturer Received: 09/14/2018; 09/06/2018
• Supplement Dates FDA Received: 09/19/2018; 09/24/2018
• Date Device Manufactured: 12/11/2003
• 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: 15 YR
• Patient Weight: 50