MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC SURGICAL CONDUIT; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number MDT-CONDUIT

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Hemorrhage/Bleeding (1888); Pleural Effusion (2010); Pulmonary Edema (2020); Pulmonary Valve Stenosis (2024); Tachycardia (2095); Low Cardiac Output (2501)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

Citation: haydin s et al.Surgical strategies and results for repair of pulmonary atresia with ventricular septal defect and major a ortopulmonary collaterals: experience of a single tertiary center.Braz j cardiovasc surg.2020 aug 1;35(4):445-451.Doi: 10.21470/1678-9741-2019-0055.Earliest date of publish used for date of event.Medtronic products referenced: contegra conduit (pma# h020003, product code mwh), hancock conduit (pma# p790007, product code lwr).Earliest approved product used for product code and pma#.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 the surgical management and outcomes of patients with pulmonary atresia and ventricular septal defect with major aortopulmonary collateral arteries.All data was retrospectively collected from a single center between january 2012 and october 2018.The study population included 36 patients and was predominantly male with a median age of 5.5 months and a median weight of 8 kg.In 14 of these patients, the right ventricle to pulmonary artery (rv-pa) connection was preserved with the implant of a medtronic valved conduit: contegra (13) or hancock (1).No serial numbers were provided.Among all patients, seven deaths occurred (3 in-hospital, 4 during follow-up).Multiple manufacturers devices were implanted in the study population.None of the deaths were directly associated with medtronic product.Among all patients, adverse events included: antiarrhythmic medication for junctional ectopic tachycardia, ventricular tachycardia, or focal atrial tachycardia; peritoneal dialysis for low cardiac output; nitric oxide inhalation therapy for high right ventricular pressure; bacterial septicemia; transient phrenic nerve paresis; chylothorax; pleural effusion; pulmonary hemorrhage; multiple reintubations due to bronchial hyperreactivity or pulmonary edema; need for extracorporeal membrane oxygenation support (weaned successfully); reoperation due to conduit stenosis; reintervention; and rv-pa conduit explanted/replaced.Based on the available information, medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: MEDTRONIC SURGICAL CONDUIT
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: 11253429
• MDR Text Key: 233285294
• Report Number: 2025587-2021-00379
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P790007
• 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: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MDT-CONDUIT
• Device Catalogue Number: MDT-CONDUIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2021
• 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): Required Intervention
• Patient Age: 6 MO
• Patient Weight: 8