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

Model Number 200S

Device Problems Partial Blockage (1065); Calcified (1077); Gradient Increase (1270)

Patient Problems Calcium Deposits/Calcification (1758); Death, Intrauterine Fetal (1855); High Blood Pressure/ Hypertension (1908); Pulmonary Regurgitation (2023); Right Ventricular Dysfunction (2054); Stenosis (2263); Vascular System (Circulation), Impaired (2572)

Event Date 01/15/2020

Event Type  Injury  

Manufacturer Narrative

Citation: detzner a., et al.Successful tpv implantation in a pregnant patient with right ventricle to pulmonary artery conduit obstruction.Jacc: case reports, january 2020; 2(1):135-138.Https://doi.Org/10.1016/j.Jaccas.2019.11.055 earliest date of publish 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 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 via literature regarding a (b)(6) year-old female patient, pregnant with twins.The patient has a history of double-outlet right ventricle who at age (b)(6) underwent a rastelli procedure to create a right ventricle-pulmonary artery conduit (rvpac).At (b)(6) year of age she underwent replacement of the rvpac with a 2-mm medtronic contegra bioprosthetic valved conduit (no serial number provided).At (b)(6) years of age the patient presented at 6 weeks¿ gestation with new year heart association (nyha) class ii functional symptoms with loud systolic/diastolic murmurs.Echocardiography confirmed moderate rvpac stenosis/regurgitation and elevated right ventricular (rv) systolic pressures.At 13 weeks¿ gestation, the patient underwent cardiac catheterization/angiography where rvpac calcification was noted, with significant elevated transvalvular gradients, conduit regurgitation, and obstructed conduit inflow/outflow.Rvpac angioplasty was performed, but elevated rv pressures persisted.The patient then underwent stenting and transcatheter pulmonary valve implantation with a 22-mm medtronic melody bioprosthetic valve (no serial numbers provided).At more than 23 weeks¿ gestation the patient experienced intrauterine demise of one of the two fetuses from unknown causes.At more than 30 weeks¿ gestation one fetus was delivered stillborn along with one live infant birth.Follow-up echocardiography at 2 years post-implantation noted excellent results with trace valvular regurgitation.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: 9833021
• MDR Text Key: 192776486
• Report Number: 2025587-2020-00774
• 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,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2020

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?: No
• 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: 02/14/2020
• Initial Date FDA Received: 03/14/2020
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 20 YR