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

Model Number 200SH16

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

Patient Problems Calcium Deposits/Calcification (1758); No Information (3190)

Event Date 05/23/2019

Event Type  Injury  

Manufacturer Narrative

Product analysis: cannot be completed since the device remains implanted in the patient.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 14 years and 6 months post implant of this 16mm pulmonary valved conduit, implanted in a 11 month old pediatric patient, the valve was replaced valve-in-valve with a transcatheter pulmonary valved conduit deployed to 22mm.The reason for valve-in-valve was not reported.No additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that the reason for replacement was severe calcification.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Corrected data: h.6: coding d.4: model #, serial # medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

B5 and 6a corrected medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Medtronic received information that 12 years and 1 month post implant of this 16mm pulmonary valved conduit, implanted in a 3 years, 5 months old pediatric patient, a transcatheter pulmonary bioprosthetic valve (tpbv) was implanted valve-in-valve.The reason for replacement was severe calcification.No additional adverse patient effects were reported.

• Brand Name: CONTEGRA
• Type of Device: PULMONIC VALVED CONDUIT
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway, MN ; EI ; 7635055378
• MDR Report Key: 8714967
• MDR Text Key: 148523559
• Report Number: 2025587-2019-01991
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/07/2024

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 Model Number: 200SH16
• Device Catalogue Number: 200SH16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 07/18/2019; 03/25/2024; 04/15/2024
• Supplement Dates FDA Received: 07/30/2019; 03/25/2024; 05/07/2024
• 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 Sex: Female
• Patient Weight: 55 KG