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

Model Number 200SH22

Device Problems Calcified (1077); Gradient Increase (1270); Incomplete Coaptation (2507); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 03/22/2019

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 3 years and 10 months post implant of this bioprosthetic pulmonary valved conduit implanted in a pediatric patient, a transcatheter pulmonary valve (tpv) was implanted valve-in-valve.The reason for replacement was not reported.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that the reason for replacement was an echocardiogram done on the patient showed his conduit had calcification and limited leaflet mobility, along with increased gradients of over 55 mmhg.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 VALVES DIVISON; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8534373
• MDR Text Key: 142600490
• Report Number: 2025587-2019-01285
• Device Sequence Number: 1
• Product Code: MWH
• 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: 05/08/2019

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: 01/13/2018
• Device Model Number: 200SH22
• Device Catalogue Number: 200SH22
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2019
• Initial Date FDA Received: 04/21/2019
• Supplement Dates Manufacturer Received: 05/08/2019
• Supplement Dates FDA Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR
• Patient Weight: 55