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

Model Number 200S

Device Problems Calcified (1077); Material Deformation (2976)

Patient Problems Bacterial Infection (1735); Pulmonary Valve Stenosis (2024); Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

Citation: hirai k, et al.Outcomes of right ventricular outflow tract reconstruction in children: retrospective comparison between bovine jugular vein and expanded polytetrafluoroethylene conduits.Pediatr cardiol.2021 jan;42(1):100-108.Doi: 10.1007/s00246-020-02458-0.Epub 2020 sep 23.Earliest date of publish used for date of event.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 from a literature article regarding a comparison of right ventricular outflow tract (rvot) reconstruction using bovine jugular vein or expanded polytetrafuoroethylene conduits.All data was retrospectively collected from a single center between january 2013 and december 2017.Of the 44 patients included in the study population, 20 patients underwent rvot reconstruction with the medtronic contegra (10 males, 10 females; mean age 2.3 years; mean weight 10.2 kg).No unique device identifier numbers were provided.The mean follow-up period was 4.9 years for the contegra group.In the contegra group, no deaths occurred during follow-up.In the contegra group, adverse events included: re-rvot reconstruction (3 cases); conduit replacement because of aneurysmal conduit dilatation associated with branch pulmonary stenosis (3 cases) or calcific conduit stenosis (1 case); stent implantation or repeat balloon angioplasty for branch pulmonary stenosis (2 cases); branch pulmonary stenosis without intervention; pulmonary regurgitation (trivial = 9 cases, mild = 8 cases, moderate = 3 cases); and bacteremia without vegetation managed with medication (1 case).No additional adverse patient effects or product performance issues were reported.

• Brand Name: CONTEGRA PULMONARY VALVED CONDUIT
• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12193395
• MDR Text Key: 262625175
• Report Number: 2025587-2021-02233
• Device Sequence Number: 1
• Product Code: MWH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H020003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2021

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: 06/23/2021
• Initial Date FDA Received: 07/19/2021
• 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; Required Intervention
• Patient Age: 2 YR
• Patient Weight: 10