MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED; CONDUIT,VALVED,PULMONIC

Model Number 200S

Device Problems Calcified (1077); Obstruction of Flow (2423); Device Markings/Labelling Problem (2911)

Patient Problems Calcium Deposits/Calcification (1758); Endocarditis (1834); Pulmonary Regurgitation (2023); Stenosis (2263); Obstruction/Occlusion (2422)

Event Date 04/17/2020

Event Type  Injury  

Manufacturer Narrative

End date of survey results used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without the return of the product, no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information through a post market clinical follow-up survey on contegra pulmonary valved conduit.Observations that were stated as related to pre-existing patient condition included: one pulmonary hypertension, one pulmonary insufficiency, one infection, and one stenosis.Observations that were stated as related to the procedure but not directly to the contegra conduit included: one endocarditis, and one prosthesis calcification or stenosis.Observations that were stated as directly related to the conduit included: one device or packaging identification issues, and one obstruction of implant with clinical impact within 60 days requiring intervention to explant conduit.No serial numbers were provided.No additional adverse patient effects or product performance issues were reported.

• Brand Name: CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED
• Type of Device: CONDUIT,VALVED,PULMONIC
• 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10054586
• MDR Text Key: 192377004
• Report Number: 2025587-2020-01626
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 200S
• Device Catalogue Number: 200S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2020
• Initial Date FDA Received: 05/13/2020
• 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): Life Threatening; Required Intervention