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

Model Number 200S

Device Problems Calcified (1077); Gradient Increase (1270); Peeled/Delaminated (1454); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problems Intimal Dissection (1333); Calcium Deposits/Calcification (1758); Endocarditis (1834); Inflammation (1932); Pulmonary Regurgitation (2023); Thrombus (2101); Stenosis (2263); Pseudoaneurysm (2605)

Event Date 09/01/2006

Event Type  Injury  

Manufacturer Narrative

Citation: raja et al.Contegra conduit: current outcomes and concerns.Expert rev cardiovasc ther.2006 sep;4(5):721-30.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.Note: two conduit-related deaths were reported due to thrombosis.A review of the referenced citations showed both events had been previously reviewed.A (b)(6) old neonate implanted with a 12-mm conduit arrested suddenly on day 5 with profound hypoxia which autopsy later found to be due to a completely thrombosed conduit (pe (b)(4) / mdr 2025587-2018-03163).In another patient a completely thrombosed conduit resulted in cardiac and hepatic failure with multiple pulmonary emboli and death (pe (b)(4) / mdr 2025587-2013-00119).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a review of contegra conduit implanted in right ventricular outflow tract (rvot) reconstruction.Data were collected from a small study and meta-analysis review of several other studies dated from 2002 to 2006.The study population included 16 patients (predominantly male, mean 69 months old, mean weight 21 kg) in the small study and the remaining patients (no demographics provided) were represented in the referenced studies.Among all patients, adverse events included: thrombosis, aneurysmal dilation, endocarditis requiring intervention, severe regurgitation, structural valve degeneration caused by fibrous peel and thrombus, intimal membrane formation causing stenosis, periadventitial or granulomatous inflammation causing disruption of the native extracellular matrix and architecture, pseudoaneurysm, confluence st enosis causing excessive gradient requiring intervention, calcification, and conduit twist requiring intervention attributed to use error (i.E.Poor implant technique).Based on the available information, medtronic product may have caused or contributed to these adverse events.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: 8427411
• MDR Text Key: 139043927
• Report Number: 2025587-2019-00952
• Device Sequence Number: 1
• Product Code: MWH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: H020003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2019

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: 02/18/2019
• Initial Date FDA Received: 03/17/2019
• 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: 69 MO
• Patient Weight: 21