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

Model Number 200S

Device Problems Calcified (1077); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Calcium Deposits/Calcification (1758); Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Ventricular Fibrillation (2130); Stenosis (2263); Thrombosis/Thrombus (4440); Cardiovascular Insufficiency (4445)

Event Date 02/23/2020

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product: hancock conduit, product id: hc150-12, serial/lot #: unknown, pma#: p790007.Citation: sirico et al.Cangrelor use in a (b)(6)-year-old patient undergoing complex percutaneous coronary intervention after post-surgical myocardial infarction.Platelets.2020 nov 16;31(8):1090-1093.Doi: 10.1080/09537104.2020.1732323.Epub 2020 feb 23.Earliest date of publish used for event date in b3.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 case report regarding a (b)(6)-month-old male patient who underwent surgical repair with ventricular septal defect (vsd) closure, left pulmonary artery origin augmentation plasty and right ventricle (rv) to pulmonary artery (pa) valved-conduit placement with a 14 mm medtronic contegra conduit (no serial numbers provided).At (b)(6) years old (and (b)(6) kg) the patient developed hemodynamically significant stenosis of the conduit with estimated maximum gradients of 90 mmhg.A diagnostic right heart catheterization and angiography showed conduit calcification with significant stenosis and complete occlusion of the left pulmonary artery.After a multi-disciplinary team discussion, the patient underwent surgical rv-to-pa conduit replacement with an 18 mm medtronic hancock conduit (no serial numbers provided).The calcified posterior wall of the degenerated contegra conduit was left in situ and the reinforcing external ring of the hancock conduit was partially removed to minimize compression on the coronary arteries underneath.After chest closure the patient became hypotensive with st segment elevation and reduced left ventricle ejection fraction to 45%.Later, in the intensive care unit the patient experienced cardiac arrest from ventricular fibrillation requiring cardiopulmonary resuscitation (cpr) and external defibrillation shocks.The patient was immediately returned to surgery where the chest was re-opened, and the conduit was manually lateralized resulting in hemodynamic improvement and partial regression of st el evation.One day later coronary angiography showed sub-occlusion at the origin of both the left anterior descending and right coronary arteries.Percutaneous coronary intervention (pci) was performed with multiple balloon dilatations without resolution of the stenoses.A repeat angiogram showed thrombus in both coronary arteries with reduced flow, and the patient became hypotensive.Subsequently, two non-medtronic drug eluting stents were successfully implanted in the proximal segments of the left anterior descending and right coronary arteries.Intravascular ultrasound and angiogram revealed good restoration of flow and stable hemodynamics.The patient¿s chest was surgically closed.Three days following pci and surgery a transthoracic echocardiogram (tte) showed moderate to severe left ventricular systolic dysfunction.The patient was treated medicinally and with antiplatelet therapy.Sixteen days following pci, pre-discharge tte showed dyskinesia of interventricular septum and hypokinesia of anterior wall with a marginal improvement of left ventricle ejection fraction.The patient was discharged home in good condition.No additional adverse patient effects or product performance issues were reported.

Event Description

Additional information received from the physician/author stated that medtronic product did not cause or contribute to the observed adverse events.No further details were provided.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 10872465
• MDR Text Key: 217337222
• Report Number: 2025587-2020-03586
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

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
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 12/01/2020
• Supplement Dates FDA Received: 12/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 6 YR
• Patient Weight: 19